Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00262600




Registration number
NCT00262600
Ethics application status
Date submitted
6/12/2005
Date registered
7/12/2005
Date last updated
17/04/2019

Titles & IDs
Public title
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
Scientific title
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Secondary ID [1] 0 0
2005-003894-26
Secondary ID [2] 0 0
1160.26
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Stroke 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - warfarin
Treatment: Drugs - Dabigatran dose 1
Treatment: Drugs - Dabigatran dose 2

Active comparator: Dabigatran dose 2 - twice a day

Active comparator: Warfarin - once a day

Active comparator: Dabigatran dose 1 - twice a day


Treatment: Drugs: warfarin
once a day

Treatment: Drugs: Dabigatran dose 1
twice daily

Treatment: Drugs: Dabigatran dose 2
twice a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Yearly Event Rate for Composite Endpoint of Stroke/SEE
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Bleeding Events (Major and Minor)
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)
Timepoint [4] 0 0
36 months
Secondary outcome [5] 0 0
Abnormal Liver Function Test
Timepoint [5] 0 0
36 months

Eligibility
Key inclusion criteria
Inclusion criteria Patients with non-valvular atrial fibrillation (AF), at moderate to high risk of stroke, or systemic embolism with at least one additional risk factor (i.e. previous ischemic stroke, TIA, or systemic embolism, left ventricular dysfunction, age >=75 years, age >=65 with either diabetes mellitus, history of coronary artery disease or hypertension)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

1. Prosthetic heart valves requiring anticoagulation per se, or hemodynamically relevant valve disease that is expected to require surgical intervention during the course of the study
2. Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
3. Conditions associated with an increased risk of bleeding
4. Contraindication to warfarin treatment
5. Reversible causes of atrial fibrillation (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
6. Plan to perform a pulmonary vein ablation or surgery for cure of the AF
7. Severe renal impairment (estimated creatinine clearance <=30 mL/min)
8. Active infective endocarditis
9. Active liver disease
10. Women who are pregnant, lactating, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
11. Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L)
12. Patients who have developed transaminase elevations upon exposure to ximelagatran
13. Patients who have received an investigational drug in the past 30 days or are participating in another drug study
14. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
15. Any known hypersensitivity to galactose if the warfarin used contains galactose.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
18113
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
1160.26.0508 Boehringer Ingelheim Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
1160.26.0510 Boehringer Ingelheim Investigational Site - Gosford
Recruitment hospital [3] 0 0
1160.26.0505 Boehringer Ingelheim Investigational Site - Herston
Recruitment hospital [4] 0 0
1160.26.0506 Boehringer Ingelheim Investigational Site - Milton
Recruitment hospital [5] 0 0
1160.26.0509 Boehringer Ingelheim Investigational Site - Ashford
Recruitment hospital [6] 0 0
1160.26.0507 Boehringer Ingelheim Investigational Site - Launceston
Recruitment hospital [7] 0 0
1160.26.0504 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [8] 0 0
1160.26.0501 Boehringer Ingelheim Investigational Site - Geelong
Recruitment hospital [9] 0 0
1160.26.0502 Boehringer Ingelheim Investigational Site - Parkville
Recruitment hospital [10] 0 0
1160.26.0503 Boehringer Ingelheim Investigational Site - Prahran
Recruitment postcode(s) [1] 0 0
- Coffs Harbour
Recruitment postcode(s) [2] 0 0
- Gosford
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Milton
Recruitment postcode(s) [5] 0 0
- Ashford
Recruitment postcode(s) [6] 0 0
- Launceston
Recruitment postcode(s) [7] 0 0
- Box Hill
Recruitment postcode(s) [8] 0 0
- Geelong
Recruitment postcode(s) [9] 0 0
- Parkville
Recruitment postcode(s) [10] 0 0
- Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Idaho
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
Country [13] 0 0
United States of America
State/province [13] 0 0
Indiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Iowa
Country [15] 0 0
United States of America
State/province [15] 0 0
Kansas
Country [16] 0 0
United States of America
State/province [16] 0 0
Kentucky
Country [17] 0 0
United States of America
State/province [17] 0 0
Louisiana
Country [18] 0 0
United States of America
State/province [18] 0 0
Maine
Country [19] 0 0
United States of America
State/province [19] 0 0
Maryland
Country [20] 0 0
United States of America
State/province [20] 0 0
Massachusetts
Country [21] 0 0
United States of America
State/province [21] 0 0
Michigan
Country [22] 0 0
United States of America
State/province [22] 0 0
Minnesota
Country [23] 0 0
United States of America
State/province [23] 0 0
Mississippi
Country [24] 0 0
United States of America
State/province [24] 0 0
Missouri
Country [25] 0 0
United States of America
State/province [25] 0 0
Montana
Country [26] 0 0
United States of America
State/province [26] 0 0
Nebraska
Country [27] 0 0
United States of America
State/province [27] 0 0
Nevada
Country [28] 0 0
United States of America
State/province [28] 0 0
New Hampshire
Country [29] 0 0
United States of America
State/province [29] 0 0
New Jersey
Country [30] 0 0
United States of America
State/province [30] 0 0
New Mexico
Country [31] 0 0
United States of America
State/province [31] 0 0
New York
Country [32] 0 0
United States of America
State/province [32] 0 0
North Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
North Dakota
Country [34] 0 0
United States of America
State/province [34] 0 0
Ohio
Country [35] 0 0
United States of America
State/province [35] 0 0
Oklahoma
Country [36] 0 0
United States of America
State/province [36] 0 0
Oregon
Country [37] 0 0
United States of America
State/province [37] 0 0
Pennsylvania
Country [38] 0 0
United States of America
State/province [38] 0 0
Rhode Island
Country [39] 0 0
United States of America
State/province [39] 0 0
South Carolina
Country [40] 0 0
United States of America
State/province [40] 0 0
South Dakota
Country [41] 0 0
United States of America
State/province [41] 0 0
Tennessee
Country [42] 0 0
United States of America
State/province [42] 0 0
Texas
Country [43] 0 0
United States of America
State/province [43] 0 0
Virginia
Country [44] 0 0
United States of America
State/province [44] 0 0
Washington
Country [45] 0 0
United States of America
State/province [45] 0 0
West Virginia
Country [46] 0 0
United States of America
State/province [46] 0 0
Wisconsin
Country [47] 0 0
Argentina
State/province [47] 0 0
Bahía Blanca
Country [48] 0 0
Argentina
State/province [48] 0 0
Capital Federal
Country [49] 0 0
Argentina
State/province [49] 0 0
Cipolletti
Country [50] 0 0
Argentina
State/province [50] 0 0
Coronel Suárez
Country [51] 0 0
Argentina
State/province [51] 0 0
Córdoba
Country [52] 0 0
Argentina
State/province [52] 0 0
La Plata
Country [53] 0 0
Argentina
State/province [53] 0 0
Mar del Plata
Country [54] 0 0
Argentina
State/province [54] 0 0
Quilmes
Country [55] 0 0
Argentina
State/province [55] 0 0
Rosario
Country [56] 0 0
Argentina
State/province [56] 0 0
Salta
Country [57] 0 0
Argentina
State/province [57] 0 0
Santa Fe
Country [58] 0 0
Austria
State/province [58] 0 0
Graz
Country [59] 0 0
Austria
State/province [59] 0 0
Linz
Country [60] 0 0
Austria
State/province [60] 0 0
Wels
Country [61] 0 0
Austria
State/province [61] 0 0
Wien
Country [62] 0 0
Austria
State/province [62] 0 0
Wr. Neustadt
Country [63] 0 0
Belgium
State/province [63] 0 0
Aalst
Country [64] 0 0
Belgium
State/province [64] 0 0
Antwerpen
Country [65] 0 0
Belgium
State/province [65] 0 0
Brasschaat
Country [66] 0 0
Belgium
State/province [66] 0 0
Brugge
Country [67] 0 0
Belgium
State/province [67] 0 0
Brussels
Country [68] 0 0
Belgium
State/province [68] 0 0
Bruxelles
Country [69] 0 0
Belgium
State/province [69] 0 0
Edegem
Country [70] 0 0
Belgium
State/province [70] 0 0
Genk
Country [71] 0 0
Belgium
State/province [71] 0 0
Gent
Country [72] 0 0
Belgium
State/province [72] 0 0
Gilly
Country [73] 0 0
Belgium
State/province [73] 0 0
Haine-St.-Paul
Country [74] 0 0
Belgium
State/province [74] 0 0
Hasselt
Country [75] 0 0
Belgium
State/province [75] 0 0
Kortrijk
Country [76] 0 0
Belgium
State/province [76] 0 0
Leuven
Country [77] 0 0
Belgium
State/province [77] 0 0
Liège
Country [78] 0 0
Belgium
State/province [78] 0 0
Mol
Country [79] 0 0
Belgium
State/province [79] 0 0
Oostende
Country [80] 0 0
Belgium
State/province [80] 0 0
Roeselare
Country [81] 0 0
Belgium
State/province [81] 0 0
Tienen
Country [82] 0 0
Belgium
State/province [82] 0 0
Turnhout
Country [83] 0 0
Brazil
State/province [83] 0 0
Belo Horizonte
Country [84] 0 0
Brazil
State/province [84] 0 0
Blumenau
Country [85] 0 0
Brazil
State/province [85] 0 0
Campinas
Country [86] 0 0
Brazil
State/province [86] 0 0
Curitiba
Country [87] 0 0
Brazil
State/province [87] 0 0
Goiania
Country [88] 0 0
Brazil
State/province [88] 0 0
Marília
Country [89] 0 0
Brazil
State/province [89] 0 0
São José do Rio Preto
Country [90] 0 0
Brazil
State/province [90] 0 0
São Paulo
Country [91] 0 0
Brazil
State/province [91] 0 0
Uberaba
Country [92] 0 0
Bulgaria
State/province [92] 0 0
Pleven
Country [93] 0 0
Bulgaria
State/province [93] 0 0
Sofia
Country [94] 0 0
Bulgaria
State/province [94] 0 0
Stara Zagora
Country [95] 0 0
Bulgaria
State/province [95] 0 0
Varna
Country [96] 0 0
Canada
State/province [96] 0 0
Alberta
Country [97] 0 0
Canada
State/province [97] 0 0
British Columbia
Country [98] 0 0
Canada
State/province [98] 0 0
Manitoba
Country [99] 0 0
Canada
State/province [99] 0 0
Newfoundland and Labrador
Country [100] 0 0
Canada
State/province [100] 0 0
Nova Scotia
Country [101] 0 0
Canada
State/province [101] 0 0
Ontario
Country [102] 0 0
Canada
State/province [102] 0 0
Quebec
Country [103] 0 0
Canada
State/province [103] 0 0
Saskatchewan
Country [104] 0 0
China
State/province [104] 0 0
Beijing
Country [105] 0 0
China
State/province [105] 0 0
Hangzhou
Country [106] 0 0
China
State/province [106] 0 0
Harbin
Country [107] 0 0
China
State/province [107] 0 0
QingDao
Country [108] 0 0
China
State/province [108] 0 0
Shanghai
Country [109] 0 0
China
State/province [109] 0 0
Shenyang
Country [110] 0 0
China
State/province [110] 0 0
Shijiazhuang
Country [111] 0 0
Colombia
State/province [111] 0 0
Bogotá
Country [112] 0 0
Czechia
State/province [112] 0 0
Brno
Country [113] 0 0
Czechia
State/province [113] 0 0
Ostrava 1
Country [114] 0 0
Czechia
State/province [114] 0 0
Pardubice
Country [115] 0 0
Czechia
State/province [115] 0 0
Plzen-Bory
Country [116] 0 0
Czechia
State/province [116] 0 0
Pragha 9
Country [117] 0 0
Czechia
State/province [117] 0 0
Prague 5
Country [118] 0 0
Czechia
State/province [118] 0 0
Praha 6
Country [119] 0 0
Czechia
State/province [119] 0 0
Pribram
Country [120] 0 0
Czechia
State/province [120] 0 0
Usti nad Orlici
Country [121] 0 0
Denmark
State/province [121] 0 0
Aalborg
Country [122] 0 0
Denmark
State/province [122] 0 0
Aarhus C
Country [123] 0 0
Denmark
State/province [123] 0 0
Frederikssund
Country [124] 0 0
Denmark
State/province [124] 0 0
Helsingør
Country [125] 0 0
Denmark
State/province [125] 0 0
Herlev
Country [126] 0 0
Denmark
State/province [126] 0 0
Horsens
Country [127] 0 0
Denmark
State/province [127] 0 0
Hvidovre
Country [128] 0 0
Denmark
State/province [128] 0 0
Køge
Country [129] 0 0
Denmark
State/province [129] 0 0
Odense
Country [130] 0 0
Denmark
State/province [130] 0 0
Roskilde
Country [131] 0 0
Denmark
State/province [131] 0 0
Svendborg
Country [132] 0 0
Finland
State/province [132] 0 0
Espoo
Country [133] 0 0
Finland
State/province [133] 0 0
HUS
Country [134] 0 0
Finland
State/province [134] 0 0
Jyväskylä
Country [135] 0 0
Finland
State/province [135] 0 0
Kuopio
Country [136] 0 0
Finland
State/province [136] 0 0
Lappeenranta
Country [137] 0 0
Finland
State/province [137] 0 0
OYS
Country [138] 0 0
Finland
State/province [138] 0 0
Pori
Country [139] 0 0
Finland
State/province [139] 0 0
Tampere
Country [140] 0 0
Finland
State/province [140] 0 0
Turku
Country [141] 0 0
France
State/province [141] 0 0
ABBEVILLE cedex
Country [142] 0 0
France
State/province [142] 0 0
Angers
Country [143] 0 0
France
State/province [143] 0 0
Cholet
Country [144] 0 0
France
State/province [144] 0 0
Gap
Country [145] 0 0
France
State/province [145] 0 0
Grenoble
Country [146] 0 0
France
State/province [146] 0 0
Joue les Tours
Country [147] 0 0
France
State/province [147] 0 0
Joué les Tours
Country [148] 0 0
France
State/province [148] 0 0
Langres
Country [149] 0 0
France
State/province [149] 0 0
Paris
Country [150] 0 0
France
State/province [150] 0 0
TOULOUSE cedex
Country [151] 0 0
France
State/province [151] 0 0
Tourcoing
Country [152] 0 0
France
State/province [152] 0 0
VALENCIENNES cedex
Country [153] 0 0
France
State/province [153] 0 0
Valenciennes cedex
Country [154] 0 0
France
State/province [154] 0 0
Valenciennes
Country [155] 0 0
Germany
State/province [155] 0 0
Berlin
Country [156] 0 0
Germany
State/province [156] 0 0
Bochum
Country [157] 0 0
Germany
State/province [157] 0 0
Coburg
Country [158] 0 0
Germany
State/province [158] 0 0
Dachau
Country [159] 0 0
Germany
State/province [159] 0 0
Dortmund
Country [160] 0 0
Germany
State/province [160] 0 0
Duisburg
Country [161] 0 0
Germany
State/province [161] 0 0
Erlangen
Country [162] 0 0
Germany
State/province [162] 0 0
Eschweiler
Country [163] 0 0
Germany
State/province [163] 0 0
Essen
Country [164] 0 0
Germany
State/province [164] 0 0
Frankfurt/Main
Country [165] 0 0
Germany
State/province [165] 0 0
Heidelberg
Country [166] 0 0
Germany
State/province [166] 0 0
Kassel
Country [167] 0 0
Germany
State/province [167] 0 0
Köln
Country [168] 0 0
Germany
State/province [168] 0 0
Lahr
Country [169] 0 0
Germany
State/province [169] 0 0
Limburg
Country [170] 0 0
Germany
State/province [170] 0 0
Mainz
Country [171] 0 0
Germany
State/province [171] 0 0
Mannheim
Country [172] 0 0
Germany
State/province [172] 0 0
München
Country [173] 0 0
Germany
State/province [173] 0 0
Papenburg
Country [174] 0 0
Germany
State/province [174] 0 0
Suhl
Country [175] 0 0
Germany
State/province [175] 0 0
Witten
Country [176] 0 0
Germany
State/province [176] 0 0
Wuppertal
Country [177] 0 0
Greece
State/province [177] 0 0
Alexandroupolis
Country [178] 0 0
Greece
State/province [178] 0 0
Athens
Country [179] 0 0
Greece
State/province [179] 0 0
Kalamaria-Thessaloniki
Country [180] 0 0
Greece
State/province [180] 0 0
Larissa
Country [181] 0 0
Greece
State/province [181] 0 0
Leivadia
Country [182] 0 0
Greece
State/province [182] 0 0
Thessaloniki
Country [183] 0 0
Greece
State/province [183] 0 0
Thiva
Country [184] 0 0
Greece
State/province [184] 0 0
Trikala
Country [185] 0 0
Greece
State/province [185] 0 0
Voula - Athens
Country [186] 0 0
Hong Kong
State/province [186] 0 0
Hong Kong
Country [187] 0 0
Hong Kong
State/province [187] 0 0
Kowloon
Country [188] 0 0
Hungary
State/province [188] 0 0
Budapest
Country [189] 0 0
Hungary
State/province [189] 0 0
Gyongyos
Country [190] 0 0
Hungary
State/province [190] 0 0
Komarom
Country [191] 0 0
Hungary
State/province [191] 0 0
Pecs
Country [192] 0 0
Hungary
State/province [192] 0 0
Veszprem
Country [193] 0 0
India
State/province [193] 0 0
Ahmedabad
Country [194] 0 0
India
State/province [194] 0 0
Bangalore
Country [195] 0 0
India
State/province [195] 0 0
Bikaner
Country [196] 0 0
India
State/province [196] 0 0
Chennai
Country [197] 0 0
India
State/province [197] 0 0
Coimbatore
Country [198] 0 0
India
State/province [198] 0 0
Hyderabad
Country [199] 0 0
India
State/province [199] 0 0
Indore
Country [200] 0 0
India
State/province [200] 0 0
Jaipur
Country [201] 0 0
India
State/province [201] 0 0
Kerala
Country [202] 0 0
India
State/province [202] 0 0
Kottayam
Country [203] 0 0
India
State/province [203] 0 0
Lucknow
Country [204] 0 0
India
State/province [204] 0 0
Ludhiana
Country [205] 0 0
India
State/province [205] 0 0
Mumbai
Country [206] 0 0
India
State/province [206] 0 0
Mysore
Country [207] 0 0
India
State/province [207] 0 0
Nagpur
Country [208] 0 0
India
State/province [208] 0 0
New Delhi
Country [209] 0 0
India
State/province [209] 0 0
Pune
Country [210] 0 0
Israel
State/province [210] 0 0
Afula
Country [211] 0 0
Israel
State/province [211] 0 0
Ashkelon
Country [212] 0 0
Israel
State/province [212] 0 0
Be´er Scheva
Country [213] 0 0
Israel
State/province [213] 0 0
Givatayim
Country [214] 0 0
Israel
State/province [214] 0 0
Hadera
Country [215] 0 0
Israel
State/province [215] 0 0
Haifa
Country [216] 0 0
Israel
State/province [216] 0 0
Holon
Country [217] 0 0
Israel
State/province [217] 0 0
Jerusalem
Country [218] 0 0
Israel
State/province [218] 0 0
Kfar Saba
Country [219] 0 0
Israel
State/province [219] 0 0
Nazareth
Country [220] 0 0
Israel
State/province [220] 0 0
Petah Tikva
Country [221] 0 0
Israel
State/province [221] 0 0
Ramat Gan
Country [222] 0 0
Israel
State/province [222] 0 0
Rehovot
Country [223] 0 0
Israel
State/province [223] 0 0
Safed
Country [224] 0 0
Israel
State/province [224] 0 0
Tel Hashomer
Country [225] 0 0
Israel
State/province [225] 0 0
Tel-Aviv
Country [226] 0 0
Israel
State/province [226] 0 0
Zerifin
Country [227] 0 0
Italy
State/province [227] 0 0
Arezzo
Country [228] 0 0
Italy
State/province [228] 0 0
Ascoli Piceno
Country [229] 0 0
Italy
State/province [229] 0 0
Bentivoglio (BO)
Country [230] 0 0
Italy
State/province [230] 0 0
Bologna
Country [231] 0 0
Italy
State/province [231] 0 0
Castelnuovo Garfagnana
Country [232] 0 0
Italy
State/province [232] 0 0
Chieti
Country [233] 0 0
Italy
State/province [233] 0 0
Colleferro
Country [234] 0 0
Italy
State/province [234] 0 0
Cremona
Country [235] 0 0
Italy
State/province [235] 0 0
Eboli
Country [236] 0 0
Italy
State/province [236] 0 0
Isernia
Country [237] 0 0
Italy
State/province [237] 0 0
Legnago
Country [238] 0 0
Italy
State/province [238] 0 0
Mantova
Country [239] 0 0
Italy
State/province [239] 0 0
Perugia SAN Sisto
Country [240] 0 0
Italy
State/province [240] 0 0
Roma
Country [241] 0 0
Italy
State/province [241] 0 0
San Bonifacio
Country [242] 0 0
Italy
State/province [242] 0 0
San Daniele Del Friuli
Country [243] 0 0
Italy
State/province [243] 0 0
Sassari
Country [244] 0 0
Japan
State/province [244] 0 0
Abeno-ku, Osaka, Osaka
Country [245] 0 0
Japan
State/province [245] 0 0
Aki-gun, Hiroshima
Country [246] 0 0
Japan
State/province [246] 0 0
Aoba-ku, Sendai, Miyagi
Country [247] 0 0
Japan
State/province [247] 0 0
Chuo-ku, Fukuoka, Fukuoka
Country [248] 0 0
Japan
State/province [248] 0 0
Chuo-ku, Kobe, Hyogo
Country [249] 0 0
Japan
State/province [249] 0 0
Chuo-ku, Osaka, Osaka
Country [250] 0 0
Japan
State/province [250] 0 0
Fujioka-shi , Gunma-ken
Country [251] 0 0
Japan
State/province [251] 0 0
Fukushima-shi,Fukushima-ken
Country [252] 0 0
Japan
State/province [252] 0 0
Higashimatsushimashi, Miyagi-ken
Country [253] 0 0
Japan
State/province [253] 0 0
Himeji, Hyogo
Country [254] 0 0
Japan
State/province [254] 0 0
Iida, Nagano
Country [255] 0 0
Japan
State/province [255] 0 0
Isesaki-shi,Gunma
Country [256] 0 0
Japan
State/province [256] 0 0
Iwakuni, Yamaguchi
Country [257] 0 0
Japan
State/province [257] 0 0
Izumi-ku, Sendai, Miyagi
Country [258] 0 0
Japan
State/province [258] 0 0
Kamigyo-ku, Kyoto
Country [259] 0 0
Japan
State/province [259] 0 0
Kawachinagano, Osaka
Country [260] 0 0
Japan
State/province [260] 0 0
Kita-ku, Osaka, Osaka
Country [261] 0 0
Japan
State/province [261] 0 0
Kita-ku, Sakai, Osaka
Country [262] 0 0
Japan
State/province [262] 0 0
Komatsu-shi,Ishikawa -ken
Country [263] 0 0
Japan
State/province [263] 0 0
Kyoto-shi,Kyoto
Country [264] 0 0
Japan
State/province [264] 0 0
Matsumoto, Nagano
Country [265] 0 0
Japan
State/province [265] 0 0
Minami-ku, Fukuoka, Fukuoka
Country [266] 0 0
Japan
State/province [266] 0 0
Minato, Tokyo
Country [267] 0 0
Japan
State/province [267] 0 0
Minato-ku, Nagoya, Aichi
Country [268] 0 0
Japan
State/province [268] 0 0
Narashino, Chiba
Country [269] 0 0
Japan
State/province [269] 0 0
Nishinomiya-shi,Hyogo
Country [270] 0 0
Japan
State/province [270] 0 0
Okayama, Okayama
Country [271] 0 0
Japan
State/province [271] 0 0
Oota, Tokyo
Country [272] 0 0
Japan
State/province [272] 0 0
Otaru, Hokkaido
Country [273] 0 0
Japan
State/province [273] 0 0
Sagamihara, Kanagawa-ken
Country [274] 0 0
Japan
State/province [274] 0 0
Sapporo-shi,Hokkai-do
Country [275] 0 0
Japan
State/province [275] 0 0
Shibuya, Tokyo
Country [276] 0 0
Japan
State/province [276] 0 0
Shinjuku, Tokyo
Country [277] 0 0
Japan
State/province [277] 0 0
Shiroishi-ku, Sapporo, Hokkaido
Country [278] 0 0
Japan
State/province [278] 0 0
Suita, Osaka
Country [279] 0 0
Japan
State/province [279] 0 0
Suita-shi, Osaka
Country [280] 0 0
Japan
State/province [280] 0 0
Sumiyoshi-ku, Osaka, Osaka
Country [281] 0 0
Japan
State/province [281] 0 0
Takatsuki-shi,Osaka
Country [282] 0 0
Japan
State/province [282] 0 0
Tokorozawa, Saitama
Country [283] 0 0
Japan
State/province [283] 0 0
Totsuka-ku, Yokohama, Kanagawa
Country [284] 0 0
Japan
State/province [284] 0 0
Tsuchiura, Ibaragi
Country [285] 0 0
Japan
State/province [285] 0 0
Ueda, Nagano
Country [286] 0 0
Japan
State/province [286] 0 0
Wakayama, Wakayama
Country [287] 0 0
Japan
State/province [287] 0 0
Yanagawa, Fukuoka
Country [288] 0 0
Japan
State/province [288] 0 0
Yao, Osaka
Country [289] 0 0
Korea, Republic of
State/province [289] 0 0
Busan
Country [290] 0 0
Korea, Republic of
State/province [290] 0 0
Chungchungnam-Do
Country [291] 0 0
Korea, Republic of
State/province [291] 0 0
Daegu
Country [292] 0 0
Korea, Republic of
State/province [292] 0 0
Gwangju
Country [293] 0 0
Korea, Republic of
State/province [293] 0 0
Incheon
Country [294] 0 0
Korea, Republic of
State/province [294] 0 0
Seoul
Country [295] 0 0
Malaysia
State/province [295] 0 0
Kajang,Selangor
Country [296] 0 0
Malaysia
State/province [296] 0 0
Kuala Lumpur
Country [297] 0 0
Malaysia
State/province [297] 0 0
Kuching
Country [298] 0 0
Malaysia
State/province [298] 0 0
Penang
Country [299] 0 0
Mexico
State/province [299] 0 0
Durango
Country [300] 0 0
Mexico
State/province [300] 0 0
Guadalajara
Country [301] 0 0
Mexico
State/province [301] 0 0
Mexico
Country [302] 0 0
Mexico
State/province [302] 0 0
México
Country [303] 0 0
Mexico
State/province [303] 0 0
San Luis Potosí
Country [304] 0 0
Netherlands
State/province [304] 0 0
Almelo
Country [305] 0 0
Netherlands
State/province [305] 0 0
Amsterdam
Country [306] 0 0
Netherlands
State/province [306] 0 0
Apeldoorn
Country [307] 0 0
Netherlands
State/province [307] 0 0
Breda
Country [308] 0 0
Netherlands
State/province [308] 0 0
Den Bosch
Country [309] 0 0
Netherlands
State/province [309] 0 0
Den Helder
Country [310] 0 0
Netherlands
State/province [310] 0 0
Deventer
Country [311] 0 0
Netherlands
State/province [311] 0 0
Dirksland
Country [312] 0 0
Netherlands
State/province [312] 0 0
Dordrecht
Country [313] 0 0
Netherlands
State/province [313] 0 0
Ede
Country [314] 0 0
Netherlands
State/province [314] 0 0
Eindhoven
Country [315] 0 0
Netherlands
State/province [315] 0 0
Enschede
Country [316] 0 0
Netherlands
State/province [316] 0 0
Goes
Country [317] 0 0
Netherlands
State/province [317] 0 0
Gorinchem
Country [318] 0 0
Netherlands
State/province [318] 0 0
Groningen
Country [319] 0 0
Netherlands
State/province [319] 0 0
Heerlen
Country [320] 0 0
Netherlands
State/province [320] 0 0
Hengelo
Country [321] 0 0
Netherlands
State/province [321] 0 0
Hilversum
Country [322] 0 0
Netherlands
State/province [322] 0 0
Hoorn
Country [323] 0 0
Netherlands
State/province [323] 0 0
Maastricht
Country [324] 0 0
Netherlands
State/province [324] 0 0
Meppel
Country [325] 0 0
Netherlands
State/province [325] 0 0
Rotterdam
Country [326] 0 0
Netherlands
State/province [326] 0 0
Sneek
Country [327] 0 0
Netherlands
State/province [327] 0 0
Spiijkenisse
Country [328] 0 0
Netherlands
State/province [328] 0 0
Terneuzen
Country [329] 0 0
Netherlands
State/province [329] 0 0
Tiel
Country [330] 0 0
Netherlands
State/province [330] 0 0
Tilburg
Country [331] 0 0
Netherlands
State/province [331] 0 0
Veldhoven
Country [332] 0 0
Netherlands
State/province [332] 0 0
Velp
Country [333] 0 0
Netherlands
State/province [333] 0 0
Venlo
Country [334] 0 0
Norway
State/province [334] 0 0
Gjøvik
Country [335] 0 0
Norway
State/province [335] 0 0
Moss
Country [336] 0 0
Norway
State/province [336] 0 0
Nordbyhagen
Country [337] 0 0
Norway
State/province [337] 0 0
Oslo
Country [338] 0 0
Norway
State/province [338] 0 0
RUD
Country [339] 0 0
Peru
State/province [339] 0 0
Bella Vista
Country [340] 0 0
Peru
State/province [340] 0 0
Jesús María
Country [341] 0 0
Peru
State/province [341] 0 0
San Isidro
Country [342] 0 0
Peru
State/province [342] 0 0
San Martín de Porres
Country [343] 0 0
Peru
State/province [343] 0 0
Urbanización Sto Tomas De San Borja
Country [344] 0 0
Philippines
State/province [344] 0 0
Manila
Country [345] 0 0
Philippines
State/province [345] 0 0
Pasig City
Country [346] 0 0
Philippines
State/province [346] 0 0
Quezon City
Country [347] 0 0
Poland
State/province [347] 0 0
Gdynia Redlowo
Country [348] 0 0
Poland
State/province [348] 0 0
Gdynia
Country [349] 0 0
Poland
State/province [349] 0 0
Katowice
Country [350] 0 0
Poland
State/province [350] 0 0
Krakow
Country [351] 0 0
Poland
State/province [351] 0 0
Pulawy
Country [352] 0 0
Poland
State/province [352] 0 0
Warsaw
Country [353] 0 0
Poland
State/province [353] 0 0
Zabrze
Country [354] 0 0
Portugal
State/province [354] 0 0
Amadora
Country [355] 0 0
Portugal
State/province [355] 0 0
Carnaxide
Country [356] 0 0
Portugal
State/province [356] 0 0
Coimbra
Country [357] 0 0
Portugal
State/province [357] 0 0
Covilhã
Country [358] 0 0
Portugal
State/province [358] 0 0
Lisboa
Country [359] 0 0
Portugal
State/province [359] 0 0
Porto
Country [360] 0 0
Portugal
State/province [360] 0 0
Setúbal
Country [361] 0 0
Romania
State/province [361] 0 0
Bucharest
Country [362] 0 0
Romania
State/province [362] 0 0
Cluj Napoca
Country [363] 0 0
Russian Federation
State/province [363] 0 0
Moscow
Country [364] 0 0
Russian Federation
State/province [364] 0 0
St. Petersburg
Country [365] 0 0
Singapore
State/province [365] 0 0
Singapore
Country [366] 0 0
Slovakia
State/province [366] 0 0
Banska Bystrica
Country [367] 0 0
Slovakia
State/province [367] 0 0
Bratislava
Country [368] 0 0
Slovakia
State/province [368] 0 0
Kosice
Country [369] 0 0
Slovakia
State/province [369] 0 0
Zilina
Country [370] 0 0
South Africa
State/province [370] 0 0
Bloemfontein
Country [371] 0 0
South Africa
State/province [371] 0 0
Boksburg
Country [372] 0 0
South Africa
State/province [372] 0 0
Cape Town
Country [373] 0 0
South Africa
State/province [373] 0 0
Johannesburg
Country [374] 0 0
South Africa
State/province [374] 0 0
Pretoria
Country [375] 0 0
South Africa
State/province [375] 0 0
Randburg
Country [376] 0 0
South Africa
State/province [376] 0 0
Somerset West
Country [377] 0 0
Spain
State/province [377] 0 0
Barcelona
Country [378] 0 0
Spain
State/province [378] 0 0
Cadiz
Country [379] 0 0
Spain
State/province [379] 0 0
Fuenlabrada (Madrid)
Country [380] 0 0
Spain
State/province [380] 0 0
Leganés, Madrid
Country [381] 0 0
Spain
State/province [381] 0 0
Madrid-San Lorenzo Del Escorial
Country [382] 0 0
Spain
State/province [382] 0 0
Madrid
Country [383] 0 0
Spain
State/province [383] 0 0
Móstoles (Madrid)
Country [384] 0 0
Spain
State/province [384] 0 0
Sabadell
Country [385] 0 0
Sweden
State/province [385] 0 0
Göteboerg
Country [386] 0 0
Sweden
State/province [386] 0 0
Jönköping
Country [387] 0 0
Sweden
State/province [387] 0 0
Linköping
Country [388] 0 0
Sweden
State/province [388] 0 0
Malmö
Country [389] 0 0
Sweden
State/province [389] 0 0
Norrköping
Country [390] 0 0
Sweden
State/province [390] 0 0
Nässjö
Country [391] 0 0
Sweden
State/province [391] 0 0
Stockholm
Country [392] 0 0
Sweden
State/province [392] 0 0
Umeå
Country [393] 0 0
Sweden
State/province [393] 0 0
Uppsala
Country [394] 0 0
Sweden
State/province [394] 0 0
Västerås
Country [395] 0 0
Sweden
State/province [395] 0 0
Örebro
Country [396] 0 0
Switzerland
State/province [396] 0 0
Basel
Country [397] 0 0
Switzerland
State/province [397] 0 0
Bellinzona
Country [398] 0 0
Switzerland
State/province [398] 0 0
Bern
Country [399] 0 0
Switzerland
State/province [399] 0 0
Lugano
Country [400] 0 0
Taiwan
State/province [400] 0 0
Changhua County
Country [401] 0 0
Taiwan
State/province [401] 0 0
Hualien
Country [402] 0 0
Taiwan
State/province [402] 0 0
Kaohsiung
Country [403] 0 0
Taiwan
State/province [403] 0 0
Taichung
Country [404] 0 0
Taiwan
State/province [404] 0 0
Tainan
Country [405] 0 0
Taiwan
State/province [405] 0 0
Taipei
Country [406] 0 0
Taiwan
State/province [406] 0 0
Taoyuan
Country [407] 0 0
Thailand
State/province [407] 0 0
Bangkok
Country [408] 0 0
Thailand
State/province [408] 0 0
Chiangmai
Country [409] 0 0
Thailand
State/province [409] 0 0
Khon Kaen
Country [410] 0 0
Thailand
State/province [410] 0 0
Muang Nakhonratchasima
Country [411] 0 0
Turkey
State/province [411] 0 0
Adana
Country [412] 0 0
Turkey
State/province [412] 0 0
Ankara
Country [413] 0 0
Turkey
State/province [413] 0 0
Izmir
Country [414] 0 0
Ukraine
State/province [414] 0 0
Dnyepropetrovsk
Country [415] 0 0
Ukraine
State/province [415] 0 0
Kharkiv
Country [416] 0 0
Ukraine
State/province [416] 0 0
Kharkov
Country [417] 0 0
Ukraine
State/province [417] 0 0
Kiev
Country [418] 0 0
Ukraine
State/province [418] 0 0
Lvov
Country [419] 0 0
United Kingdom
State/province [419] 0 0
Birmingham
Country [420] 0 0
United Kingdom
State/province [420] 0 0
Chertsey
Country [421] 0 0
United Kingdom
State/province [421] 0 0
Glasgow
Country [422] 0 0
United Kingdom
State/province [422] 0 0
Harrow
Country [423] 0 0
United Kingdom
State/province [423] 0 0
Hull
Country [424] 0 0
United Kingdom
State/province [424] 0 0
Kirkcaldy, Fife
Country [425] 0 0
United Kingdom
State/province [425] 0 0
Londonderry
Country [426] 0 0
United Kingdom
State/province [426] 0 0
London
Country [427] 0 0
United Kingdom
State/province [427] 0 0
Newcastle upon Tyne
Country [428] 0 0
United Kingdom
State/province [428] 0 0
Newport
Country [429] 0 0
United Kingdom
State/province [429] 0 0
Northampton
Country [430] 0 0
United Kingdom
State/province [430] 0 0
Portadown, County Atrim
Country [431] 0 0
United Kingdom
State/province [431] 0 0
Romford, Essex
Country [432] 0 0
United Kingdom
State/province [432] 0 0
Stoke-On-Trent
Country [433] 0 0
United Kingdom
State/province [433] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Population Health Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Uppsala University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
Trial website
https://clinicaltrials.gov/study/NCT00262600
Trial related presentations / publications
Reinhardt SW, Desai NR, Tang Y, Jones PG, Ader J, Spertus JA. Personalizing the decision of dabigatran versus warfarin in atrial fibrillation: A secondary analysis of the Randomized Evaluation of Long-term anticoagulation therapY (RE-LY) trial. PLoS One. 2021 Aug 19;16(8):e0256338. doi: 10.1371/journal.pone.0256338. eCollection 2021.
Pol T, Hijazi Z, Lindback J, Oldgren J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Yusuf S, Siegbahn A, Wallentin L. Using multimarker screening to identify biomarkers associated with cardiovascular death in patients with atrial fibrillation. Cardiovasc Res. 2022 Jul 20;118(9):2112-2123. doi: 10.1093/cvr/cvab262.
Millenaar D, Schumacher H, Brueckmann M, Eikelboom JW, Ezekowitz M, Slawik J, Ewen S, Ukena C, Wallentin L, Connolly S, Yusuf S, Bohm M. Cardiovascular Outcomes According to Polypharmacy and Drug Adherence in Patients with Atrial Fibrillation on Long-Term Anticoagulation (from the RE-LY Trial). Am J Cardiol. 2021 Jun 15;149:27-35. doi: 10.1016/j.amjcard.2021.03.024. Epub 2021 Mar 20.
Pol T, Hijazi Z, Lindback J, Alexander JH, Bahit MC, De Caterina R, Eikelboom JW, Ezekowitz MD, Gersh BJ, Granger CB, Hylek EM, Lopes R, Siegbahn A, Wallentin L. Evaluation of the prognostic value of GDF-15, ABC-AF-bleeding score and ABC-AF-death score in patients with atrial fibrillation across different geographical areas. Open Heart. 2021 Mar;8(1):e001471. doi: 10.1136/openhrt-2020-001471.
Hijazi Z, Wallentin L, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Pol T, Yusuf S, Oldgren J, Siegbahn A. Screening of Multiple Biomarkers Associated With Ischemic Stroke in Atrial Fibrillation. J Am Heart Assoc. 2020 Dec 15;9(24):e018984. doi: 10.1161/JAHA.120.018984. Epub 2020 Dec 9.
Wallentin L, Lindback J, Eriksson N, Hijazi Z, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Yusuf S, Oldgren J, Siegbahn A. Angiotensin-converting enzyme 2 (ACE2) levels in relation to risk factors for COVID-19 in two large cohorts of patients with atrial fibrillation. Eur Heart J. 2020 Nov 1;41(41):4037-4046. doi: 10.1093/eurheartj/ehaa697.
Bohm M, Brueckmann M, Eikelboom JW, Ezekowitz M, Frassdorf M, Hijazi Z, Hohnloser SH, Mahfoud F, Schmieder RE, Schumacher H, Wallentin L, Yusuf S. Cardiovascular outcomes, bleeding risk, and achieved blood pressure in patients on long-term anticoagulation with the thrombin antagonist dabigatran or warfarin: data from the RE-LY trial. Eur Heart J. 2020 Aug 7;41(30):2848-2859. doi: 10.1093/eurheartj/ehaa247.
Stam-Slob MC, Connolly SJ, van der Graaf Y, van der Leeuw J, Dorresteijn JAN, Eikelboom JW, Peters RJG, Alings M, Visseren FLJ. Individual Treatment Effect Estimation of 2 Doses of Dabigatran on Stroke and Major Bleeding in Atrial Fibrillation. Circulation. 2019 Jun 18;139(25):2846-2856. doi: 10.1161/CIRCULATIONAHA.118.035266. Epub 2019 May 3.
Hijazi Z, Verdecchia P, Oldgren J, Andersson U, Reboldi G, Di Pasquale G, Mazzotta G, Angeli F, Eikelboom JW, Ezekowitz MD, Connolly SJ, Yusuf S, Wallentin L. Cardiac Biomarkers and Left Ventricular Hypertrophy in Relation to Outcomes in Patients With Atrial Fibrillation: Experiences From the RE - LY Trial. J Am Heart Assoc. 2019 Jan 22;8(2):e010107. doi: 10.1161/JAHA.118.010107.
Kent AP, Brueckmann M, Fraessdorf M, Connolly SJ, Yusuf S, Eikelboom JW, Oldgren J, Reilly PA, Wallentin L, Ezekowitz MD. Concomitant Oral Anticoagulant and Nonsteroidal Anti-Inflammatory Drug Therapy in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2018 Jul 17;72(3):255-267. doi: 10.1016/j.jacc.2018.04.063. Epub 2018 Jul 9.
Hijazi Z, Hohnloser SH, Oldgren J, Andersson U, Connolly SJ, Eikelboom JW, Ezekowitz MD, Reilly PA, Yusuf S, Wallentin L. Efficacy and safety of dabigatran compared with warfarin in patients with atrial fibrillation in relation to renal function over time-A RE-LY trial analysis. Am Heart J. 2018 Apr;198:169-177. doi: 10.1016/j.ahj.2017.10.015. Epub 2018 Jan 5. No abstract available.
Hijazi Z, Oldgren J, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Yusuf S, Granger CB, Siegbahn A, Wallentin L; ARISTOTLE and RE-LY Investigators. A biomarker-based risk score to predict death in patients with atrial fibrillation: the ABC (age, biomarkers, clinical history) death risk score. Eur Heart J. 2018 Feb 7;39(6):477-485. doi: 10.1093/eurheartj/ehx584.
Verdecchia P, Reboldi G, Angeli F, Mazzotta G, Lip GYH, Brueckmann M, Kleine E, Wallentin L, Ezekowitz MD, Yusuf S, Connolly SJ, Di Pasquale G. Dabigatran vs. warfarin in relation to the presence of left ventricular hypertrophy in patients with atrial fibrillation- the Randomized Evaluation of Long-term anticoagulation therapY (RE-LY) study. Europace. 2018 Feb 1;20(2):253-262. doi: 10.1093/europace/eux022.
Lauw MN, Eikelboom JW, Coppens M, Wallentin L, Yusuf S, Ezekowitz M, Oldgren J, Nakamya J, Wang J, Connolly SJ. Effects of dabigatran according to age in atrial fibrillation. Heart. 2017 Jul;103(13):1015-1023. doi: 10.1136/heartjnl-2016-310358. Epub 2017 Feb 17.
Oldgren J, Hijazi Z, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Hylek EM, Lopes RD, Siegbahn A, Yusuf S, Wallentin L; RE-LY and ARISTOTLE Investigators. Performance and Validation of a Novel Biomarker-Based Stroke Risk Score for Atrial Fibrillation. Circulation. 2016 Nov 29;134(22):1697-1707. doi: 10.1161/CIRCULATIONAHA.116.022802. Epub 2016 Aug 28.
Ezekowitz MD, Nagarakanti R, Noack H, Brueckmann M, Litherland C, Jacobs M, Clemens A, Reilly PA, Connolly SJ, Yusuf S, Wallentin L. Comparison of Dabigatran and Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: The RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulant Therapy). Circulation. 2016 Aug 23;134(8):589-98. doi: 10.1161/CIRCULATIONAHA.115.020950. Epub 2016 Aug 5.
Hijazi Z, Oldgren J, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Siegbahn A, Yusuf S, Granger CB, Wallentin L; ARISTOTLE and RE-LY Investigators. The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study. Lancet. 2016 Jun 4;387(10035):2302-2311. doi: 10.1016/S0140-6736(16)00741-8. Epub 2016 Apr 4.
Siegbahn A, Oldgren J, Andersson U, Ezekowitz MD, Reilly PA, Connolly SJ, Yusuf S, Wallentin L, Eikelboom JW. D-dimer and factor VIIa in atrial fibrillation - prognostic values for cardiovascular events and effects of anticoagulation therapy. A RE-LY substudy. Thromb Haemost. 2016 May 2;115(5):921-30. doi: 10.1160/TH15-07-0529. Epub 2016 Jan 28.
Aulin J, Siegbahn A, Hijazi Z, Ezekowitz MD, Andersson U, Connolly SJ, Huber K, Reilly PA, Wallentin L, Oldgren J. Interleukin-6 and C-reactive protein and risk for death and cardiovascular events in patients with atrial fibrillation. Am Heart J. 2015 Dec;170(6):1151-60. doi: 10.1016/j.ahj.2015.09.018. Epub 2015 Oct 3.
Brambatti M, Darius H, Oldgren J, Clemens A, Noack HH, Brueckmann M, Yusuf S, Wallentin L, Ezekowitz MD, Connolly SJ, Healey JS. Comparison of dabigatran versus warfarin in diabetic patients with atrial fibrillation: Results from the RE-LY trial. Int J Cardiol. 2015 Oct 1;196:127-31. doi: 10.1016/j.ijcard.2015.05.141. Epub 2015 May 28.
Bohm M, Ezekowitz MD, Connolly SJ, Eikelboom JW, Hohnloser SH, Reilly PA, Schumacher H, Brueckmann M, Schirmer SH, Kratz MT, Yusuf S, Diener HC, Hijazi Z, Wallentin L. Changes in Renal Function in Patients With Atrial Fibrillation: An Analysis From the RE-LY Trial. J Am Coll Cardiol. 2015 Jun 16;65(23):2481-93. doi: 10.1016/j.jacc.2015.03.577.
Hijazi Z, Oldgren J, Andersson U, Connolly SJ, Ezekowitz MD, Hohnloser SH, Reilly PA, Siegbahn A, Yusuf S, Wallentin L. Importance of persistent elevation of cardiac biomarkers in atrial fibrillation: a RE-LY substudy. Heart. 2014 Aug;100(15):1193-200. doi: 10.1136/heartjnl-2013-304872. Epub 2014 May 2.
Verdecchia P, Reboldi G, Di Pasquale G, Mazzotta G, Ambrosio G, Yang S, Pogue J, Wallentin L, Ezekowitz MD, Connolly SJ, Yusuf S; RE-LY Study Investigators. Prognostic usefulness of left ventricular hypertrophy by electrocardiography in patients with atrial fibrillation (from the Randomized Evaluation of Long-Term Anticoagulant Therapy Study). Am J Cardiol. 2014 Feb 15;113(4):669-75. doi: 10.1016/j.amjcard.2013.10.045. Epub 2013 Nov 23.
Hijazi Z, Hohnloser SH, Oldgren J, Andersson U, Connolly SJ, Eikelboom JW, Ezekowitz MD, Reilly PA, Siegbahn A, Yusuf S, Wallentin L. Efficacy and safety of dabigatran compared with warfarin in relation to baseline renal function in patients with atrial fibrillation: a RE-LY (Randomized Evaluation of Long-term Anticoagulation Therapy) trial analysis. Circulation. 2014 Mar 4;129(9):961-70. doi: 10.1161/CIRCULATIONAHA.113.003628. Epub 2013 Dec 9.
Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.
Reilly PA, Lehr T, Haertter S, Connolly SJ, Yusuf S, Eikelboom JW, Ezekowitz MD, Nehmiz G, Wang S, Wallentin L; RE-LY Investigators. The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy). J Am Coll Cardiol. 2014 Feb 4;63(4):321-8. doi: 10.1016/j.jacc.2013.07.104. Epub 2013 Sep 27.
Marijon E, Le Heuzey JY, Connolly S, Yang S, Pogue J, Brueckmann M, Eikelboom J, Themeles E, Ezekowitz M, Wallentin L, Yusuf S; RE-LY Investigators. Causes of death and influencing factors in patients with atrial fibrillation: a competing-risk analysis from the randomized evaluation of long-term anticoagulant therapy study. Circulation. 2013 Nov 12;128(20):2192-201. doi: 10.1161/CIRCULATIONAHA.112.000491. Epub 2013 Sep 9.
Eikelboom JW, Connolly SJ, Hart RG, Wallentin L, Reilly P, Oldgren J, Yang S, Yusuf S. Balancing the benefits and risks of 2 doses of dabigatran compared with warfarin in atrial fibrillation. J Am Coll Cardiol. 2013 Sep 3;62(10):900-8. doi: 10.1016/j.jacc.2013.05.042. Epub 2013 Jun 13.
Hori M, Connolly SJ, Zhu J, Liu LS, Lau CP, Pais P, Xavier D, Kim SS, Omar R, Dans AL, Tan RS, Chen JH, Tanomsup S, Watanabe M, Koyanagi M, Ezekowitz MD, Reilly PA, Wallentin L, Yusuf S; RE-LY Investigators. Dabigatran versus warfarin: effects on ischemic and hemorrhagic strokes and bleeding in Asians and non-Asians with atrial fibrillation. Stroke. 2013 Jul;44(7):1891-6. doi: 10.1161/STROKEAHA.113.000990. Epub 2013 Jun 6.
Pare G, Eriksson N, Lehr T, Connolly S, Eikelboom J, Ezekowitz MD, Axelsson T, Haertter S, Oldgren J, Reilly P, Siegbahn A, Syvanen AC, Wadelius C, Wadelius M, Zimdahl-Gelling H, Yusuf S, Wallentin L. Genetic determinants of dabigatran plasma levels and their relation to bleeding. Circulation. 2013 Apr 2;127(13):1404-12. doi: 10.1161/CIRCULATIONAHA.112.001233. Epub 2013 Mar 6.
Dans AL, Connolly SJ, Wallentin L, Yang S, Nakamya J, Brueckmann M, Ezekowitz M, Oldgren J, Eikelboom JW, Reilly PA, Yusuf S. Concomitant use of antiplatelet therapy with dabigatran or warfarin in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Circulation. 2013 Feb 5;127(5):634-40. doi: 10.1161/CIRCULATIONAHA.112.115386. Epub 2012 Dec 27.
Bytzer P, Connolly SJ, Yang S, Ezekowitz M, Formella S, Reilly PA, Aisenberg J. Analysis of upper gastrointestinal adverse events among patients given dabigatran in the RE-LY trial. Clin Gastroenterol Hepatol. 2013 Mar;11(3):246-52.e1-5. doi: 10.1016/j.cgh.2012.10.021. Epub 2012 Oct 24.
Van Spall HG, Wallentin L, Yusuf S, Eikelboom JW, Nieuwlaat R, Yang S, Kabali C, Reilly PA, Ezekowitz MD, Connolly SJ. Variation in warfarin dose adjustment practice is responsible for differences in the quality of anticoagulation control between centers and countries: an analysis of patients receiving warfarin in the randomized evaluation of long-term anticoagulation therapy (RE-LY) trial. Circulation. 2012 Nov 6;126(19):2309-16. doi: 10.1161/CIRCULATIONAHA.112.101808. Epub 2012 Oct 1.
Healey JS, Eikelboom J, Douketis J, Wallentin L, Oldgren J, Yang S, Themeles E, Heidbuchel H, Avezum A, Reilly P, Connolly SJ, Yusuf S, Ezekowitz M; RE-LY Investigators. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial. Circulation. 2012 Jul 17;126(3):343-8. doi: 10.1161/CIRCULATIONAHA.111.090464. Epub 2012 Jun 14. Erratum In: Circulation. 2012 Sep 4;126(10):e160. Heidbuchle, Hein [corrected to Heidbuchel, Hein].
Hijazi Z, Oldgren J, Andersson U, Connolly SJ, Ezekowitz MD, Hohnloser SH, Reilly PA, Vinereanu D, Siegbahn A, Yusuf S, Wallentin L. Cardiac biomarkers are associated with an increased risk of stroke and death in patients with atrial fibrillation: a Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) substudy. Circulation. 2012 Apr 3;125(13):1605-16. doi: 10.1161/CIRCULATIONAHA.111.038729. Epub 2012 Feb 28.
Hohnloser SH, Oldgren J, Yang S, Wallentin L, Ezekowitz M, Reilly P, Eikelboom J, Brueckmann M, Yusuf S, Connolly SJ. Myocardial ischemic events in patients with atrial fibrillation treated with dabigatran or warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial. Circulation. 2012 Feb 7;125(5):669-76. doi: 10.1161/CIRCULATIONAHA.111.055970. Epub 2012 Jan 3.
Oldgren J, Alings M, Darius H, Diener HC, Eikelboom J, Ezekowitz MD, Kamensky G, Reilly PA, Yang S, Yusuf S, Wallentin L, Connolly SJ; RE-LY Investigators. Risks for stroke, bleeding, and death in patients with atrial fibrillation receiving dabigatran or warfarin in relation to the CHADS2 score: a subgroup analysis of the RE-LY trial. Ann Intern Med. 2011 Nov 15;155(10):660-7, W204. doi: 10.7326/0003-4819-155-10-201111150-00004.
Eikelboom JW, Wallentin L, Connolly SJ, Ezekowitz M, Healey JS, Oldgren J, Yang S, Alings M, Kaatz S, Hohnloser SH, Diener HC, Franzosi MG, Huber K, Reilly P, Varrone J, Yusuf S. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation. 2011 May 31;123(21):2363-72. doi: 10.1161/CIRCULATIONAHA.110.004747. Epub 2011 May 16.
Nagarakanti R, Ezekowitz MD, Oldgren J, Yang S, Chernick M, Aikens TH, Flaker G, Brugada J, Kamensky G, Parekh A, Reilly PA, Yusuf S, Connolly SJ. Dabigatran versus warfarin in patients with atrial fibrillation: an analysis of patients undergoing cardioversion. Circulation. 2011 Jan 18;123(2):131-6. doi: 10.1161/CIRCULATIONAHA.110.977546. Epub 2011 Jan 3.
Ezekowitz MD, Wallentin L, Connolly SJ, Parekh A, Chernick MR, Pogue J, Aikens TH, Yang S, Reilly PA, Lip GY, Yusuf S; RE-LY Steering Committee and Investigators. Dabigatran and warfarin in vitamin K antagonist-naive and -experienced cohorts with atrial fibrillation. Circulation. 2010 Nov 30;122(22):2246-53. doi: 10.1161/CIRCULATIONAHA.110.973735.
Diener HC, Connolly SJ, Ezekowitz MD, Wallentin L, Reilly PA, Yang S, Xavier D, Di Pasquale G, Yusuf S; RE-LY study group. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. Lancet Neurol. 2010 Dec;9(12):1157-1163. doi: 10.1016/S1474-4422(10)70274-X. Epub 2010 Nov 6. Erratum In: Lancet Neurol. 2011 Jan;10(1):27.
Wallentin L, Yusuf S, Ezekowitz MD, Alings M, Flather M, Franzosi MG, Pais P, Dans A, Eikelboom J, Oldgren J, Pogue J, Reilly PA, Yang S, Connolly SJ; RE-LY investigators. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet. 2010 Sep 18;376(9745):975-83. doi: 10.1016/S0140-6736(10)61194-4.
Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30. Erratum In: N Engl J Med. 2010 Nov 4;363(19):1877.
Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009 May;157(5):805-10, 810.e1-2. doi: 10.1016/j.ahj.2009.02.005.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00262600