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/NCT02293395




Registration number
NCT02293395
Ethics application status
Date submitted
13/11/2014
Date registered
18/11/2014
Date last updated
26/12/2017

Titles & IDs
Public title
A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome
Scientific title
A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrome
Secondary ID [1] 0 0
RIVAROXACS2002
Secondary ID [2] 0 0
CR106261
Universal Trial Number (UTN)
Trial acronym
GEMINI ACS 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Acetylsalicylic acid
Treatment: Drugs - Rivaroxaban
Treatment: Drugs - Clopidogrel
Treatment: Drugs - Ticagrelor

Active comparator: Stratum 1/ASA - Acetylsalicylic acid (ASA) 100 milligram (mg) enteric-coated tablet once daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.

Experimental: Stratum 1/Rivaroxaban - Rivaroxaban 2.5 mg tablet twice daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.

Active comparator: Stratum 2/ASA - ASA 100 mg enteric-coated tablet once daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.

Experimental: Stratum 2/Rivaroxaban - Rivaroxaban 2.5 mg tablet twice daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.


Treatment: Drugs: Acetylsalicylic acid
ASA 100 mg enteric-coated tablet once daily orally.

Treatment: Drugs: Rivaroxaban
Rivaroxaban 2.5 mg tablet twice daily orally.

Treatment: Drugs: Clopidogrel
Clopidogrel 75 mg once daily orally.

Treatment: Drugs: Ticagrelor
Ticagrelor 90 mg twice daily orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events
Timepoint [1] 0 0
From start of study treatment until follow-up (up to 390 days)

Eligibility
Key inclusion criteria
* Participants, 18 years or older, must have symptoms suggestive of acute coronary syndrome (ACS) (angina, or symptoms thought to be equivalent) within 48 hours of hospital presentation, or developed ACS while being hospitalized, and has a diagnosis of: a) ST segment elevation myocardial infarction (STEMI); b) non-ST-segment elevation acute coronary syndrome (NSTE-ACS). However, participant who is 54 years of age or younger must also have either diabetes mellitus or a history of a prior myocardial infarction (MI), in addition to the presenting ACS event
* Participant must be randomized within the screening window of 10 days after hospital admission for the index ACS event. Participant should have received acute phase treatment for the index ACS, such as intravenous anticoagulant or antiplatelet, and are receiving maintenance dual antiplatelet therapy (DAPT) with either clopidogrel plus acetyl salicylic acid (ASA), or ticagrelor plus ASA, with the intent to continue the treatment with a platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor) after randomization
* Participants must agree to provide a pharmacogenomics deoxyribonucleic acid (DNA) sample
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant has any conditions that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk
* Participant with a prior stroke of any etiology or transient ischemic attack (TIA)
* Participant who received thrombolytic therapy as treatment for the index ACS event cannot be enrolled in the ticagrelor stratum
* Participant has anticipated need for chronic administration of omeprazole or esomeprazole concomitantly with clopidogrel
* Participant has known allergy or intolerance to ASA or rivaroxaban

Study design
Purpose of the study
Treatment
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?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
20/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/10/2016
Sample size
Target
Accrual to date
Final
3037
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Brisbane
Recruitment hospital [2] 0 0
- Cairns
Recruitment hospital [3] 0 0
- Chermside
Recruitment hospital [4] 0 0
- Elizabeth Vale
Recruitment hospital [5] 0 0
- Herston
Recruitment hospital [6] 0 0
- Hobart
Recruitment hospital [7] 0 0
- Launceston
Recruitment hospital [8] 0 0
- Liverpool
Recruitment hospital [9] 0 0
- Murdoch
Recruitment hospital [10] 0 0
- Nambour
Recruitment hospital [11] 0 0
- New Lambton Heights
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Cairns
Recruitment postcode(s) [3] 0 0
- Chermside
Recruitment postcode(s) [4] 0 0
- Elizabeth Vale
Recruitment postcode(s) [5] 0 0
- Herston
Recruitment postcode(s) [6] 0 0
- Hobart
Recruitment postcode(s) [7] 0 0
- Launceston
Recruitment postcode(s) [8] 0 0
- Liverpool
Recruitment postcode(s) [9] 0 0
- Murdoch
Recruitment postcode(s) [10] 0 0
- Nambour
Recruitment postcode(s) [11] 0 0
- New Lambton Heights
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Montana
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Dakota
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Caba
Country [25] 0 0
Argentina
State/province [25] 0 0
Ciudad De Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Cordooba
Country [27] 0 0
Argentina
State/province [27] 0 0
Corrientes
Country [28] 0 0
Argentina
State/province [28] 0 0
Córdoba
Country [29] 0 0
Argentina
State/province [29] 0 0
La Plata
Country [30] 0 0
Argentina
State/province [30] 0 0
Mar Del Plata
Country [31] 0 0
Argentina
State/province [31] 0 0
Resistencia
Country [32] 0 0
Argentina
State/province [32] 0 0
Rosario
Country [33] 0 0
Argentina
State/province [33] 0 0
Salta
Country [34] 0 0
Argentina
State/province [34] 0 0
San Martín
Country [35] 0 0
Argentina
State/province [35] 0 0
Santa Fe
Country [36] 0 0
Belgium
State/province [36] 0 0
Antwerpen
Country [37] 0 0
Belgium
State/province [37] 0 0
Bonheiden
Country [38] 0 0
Belgium
State/province [38] 0 0
Brasschaat
Country [39] 0 0
Belgium
State/province [39] 0 0
Brugge
Country [40] 0 0
Belgium
State/province [40] 0 0
Edegem
Country [41] 0 0
Belgium
State/province [41] 0 0
Genk
Country [42] 0 0
Belgium
State/province [42] 0 0
Gent
Country [43] 0 0
Belgium
State/province [43] 0 0
Huy
Country [44] 0 0
Belgium
State/province [44] 0 0
Liège
Country [45] 0 0
Belgium
State/province [45] 0 0
Mol
Country [46] 0 0
Belgium
State/province [46] 0 0
Roeselare
Country [47] 0 0
Belgium
State/province [47] 0 0
Ronse
Country [48] 0 0
Belgium
State/province [48] 0 0
Turnhout
Country [49] 0 0
Brazil
State/province [49] 0 0
Belo Horizonte
Country [50] 0 0
Brazil
State/province [50] 0 0
Blumenau
Country [51] 0 0
Brazil
State/province [51] 0 0
Campina Grande Do Sul
Country [52] 0 0
Brazil
State/province [52] 0 0
Campinas
Country [53] 0 0
Brazil
State/province [53] 0 0
Curitiba
Country [54] 0 0
Brazil
State/province [54] 0 0
Marília
Country [55] 0 0
Brazil
State/province [55] 0 0
Passo Fundo
Country [56] 0 0
Brazil
State/province [56] 0 0
Porto Alegre
Country [57] 0 0
Brazil
State/province [57] 0 0
Recife
Country [58] 0 0
Brazil
State/province [58] 0 0
Salvador
Country [59] 0 0
Brazil
State/province [59] 0 0
São José Do Rio Preto
Country [60] 0 0
Brazil
State/province [60] 0 0
São Paulo
Country [61] 0 0
Brazil
State/province [61] 0 0
Tatuí
Country [62] 0 0
Brazil
State/province [62] 0 0
Uberlândia
Country [63] 0 0
Brazil
State/province [63] 0 0
Votuporanga
Country [64] 0 0
Bulgaria
State/province [64] 0 0
Blagoevgrad
Country [65] 0 0
Bulgaria
State/province [65] 0 0
Burgas
Country [66] 0 0
Bulgaria
State/province [66] 0 0
Haskovo
Country [67] 0 0
Bulgaria
State/province [67] 0 0
Lovech
Country [68] 0 0
Bulgaria
State/province [68] 0 0
Pazardzhik
Country [69] 0 0
Bulgaria
State/province [69] 0 0
Pleven
Country [70] 0 0
Bulgaria
State/province [70] 0 0
Ruse
Country [71] 0 0
Bulgaria
State/province [71] 0 0
Sandanski
Country [72] 0 0
Bulgaria
State/province [72] 0 0
Sofia
Country [73] 0 0
Bulgaria
State/province [73] 0 0
Varna
Country [74] 0 0
Canada
State/province [74] 0 0
Alberta
Country [75] 0 0
Canada
State/province [75] 0 0
British Columbia
Country [76] 0 0
Canada
State/province [76] 0 0
Ontario
Country [77] 0 0
Canada
State/province [77] 0 0
Quebec
Country [78] 0 0
Canada
State/province [78] 0 0
Québec
Country [79] 0 0
Czechia
State/province [79] 0 0
Brno
Country [80] 0 0
Czechia
State/province [80] 0 0
Kolin Iii.
Country [81] 0 0
Czechia
State/province [81] 0 0
Ostrava
Country [82] 0 0
Czechia
State/province [82] 0 0
Plzen-Bory
Country [83] 0 0
Czechia
State/province [83] 0 0
Praha 1
Country [84] 0 0
Czechia
State/province [84] 0 0
Praha 2
Country [85] 0 0
Czechia
State/province [85] 0 0
Trebic
Country [86] 0 0
Czechia
State/province [86] 0 0
Znojmo
Country [87] 0 0
Denmark
State/province [87] 0 0
Herlev
Country [88] 0 0
Denmark
State/province [88] 0 0
Koge
Country [89] 0 0
Denmark
State/province [89] 0 0
Silkeborg
Country [90] 0 0
France
State/province [90] 0 0
Besançon
Country [91] 0 0
France
State/province [91] 0 0
Chambray Les Tours
Country [92] 0 0
France
State/province [92] 0 0
Jossigny
Country [93] 0 0
France
State/province [93] 0 0
Le Coudray
Country [94] 0 0
France
State/province [94] 0 0
Lyon
Country [95] 0 0
France
State/province [95] 0 0
Montauban
Country [96] 0 0
France
State/province [96] 0 0
Nantes Cedex 1
Country [97] 0 0
France
State/province [97] 0 0
Nantes
Country [98] 0 0
France
State/province [98] 0 0
Périgueux
Country [99] 0 0
Hungary
State/province [99] 0 0
Balatonfüred
Country [100] 0 0
Hungary
State/province [100] 0 0
Budapest
Country [101] 0 0
Hungary
State/province [101] 0 0
Debrecen
Country [102] 0 0
Hungary
State/province [102] 0 0
Gyula
Country [103] 0 0
Hungary
State/province [103] 0 0
Gyor
Country [104] 0 0
Hungary
State/province [104] 0 0
Kaposvar
Country [105] 0 0
Hungary
State/province [105] 0 0
Kecskemét
Country [106] 0 0
Hungary
State/province [106] 0 0
Nyíregyháza
Country [107] 0 0
Hungary
State/province [107] 0 0
Szolnok
Country [108] 0 0
Hungary
State/province [108] 0 0
Székesfehérvár
Country [109] 0 0
Japan
State/province [109] 0 0
Gifu
Country [110] 0 0
Japan
State/province [110] 0 0
Kagawa
Country [111] 0 0
Japan
State/province [111] 0 0
Kitakyushu-City
Country [112] 0 0
Japan
State/province [112] 0 0
Kobe-Shi
Country [113] 0 0
Japan
State/province [113] 0 0
Kumamoto-Shi
Country [114] 0 0
Japan
State/province [114] 0 0
Kumamoto
Country [115] 0 0
Japan
State/province [115] 0 0
Matsue-Shi
Country [116] 0 0
Japan
State/province [116] 0 0
Nagano-Shi
Country [117] 0 0
Japan
State/province [117] 0 0
Osaka-Shi
Country [118] 0 0
Japan
State/province [118] 0 0
Sayama-Shi
Country [119] 0 0
Japan
State/province [119] 0 0
Tokyo
Country [120] 0 0
Japan
State/province [120] 0 0
Uwajima-Shi
Country [121] 0 0
Japan
State/province [121] 0 0
Yokohama
Country [122] 0 0
Japan
State/province [122] 0 0
Yonago
Country [123] 0 0
Japan
State/province [123] 0 0
Yotsui 2-8-1
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Gwangju
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Incheon
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Seongnam
Country [127] 0 0
Korea, Republic of
State/province [127] 0 0
Seoul
Country [128] 0 0
Korea, Republic of
State/province [128] 0 0
Suwon
Country [129] 0 0
Netherlands
State/province [129] 0 0
Amersfoort
Country [130] 0 0
Netherlands
State/province [130] 0 0
Amsterdam
Country [131] 0 0
Netherlands
State/province [131] 0 0
Blaricum
Country [132] 0 0
Netherlands
State/province [132] 0 0
Den Haag
Country [133] 0 0
Netherlands
State/province [133] 0 0
Den Helder
Country [134] 0 0
Netherlands
State/province [134] 0 0
Gouda
Country [135] 0 0
Netherlands
State/province [135] 0 0
Groningen
Country [136] 0 0
Netherlands
State/province [136] 0 0
Hoofddorp
Country [137] 0 0
Netherlands
State/province [137] 0 0
Hoogeveen
Country [138] 0 0
Netherlands
State/province [138] 0 0
Nijmegen
Country [139] 0 0
Netherlands
State/province [139] 0 0
Rotterdam
Country [140] 0 0
Netherlands
State/province [140] 0 0
S-Hertogenbosch
Country [141] 0 0
Netherlands
State/province [141] 0 0
Schiedam
Country [142] 0 0
Poland
State/province [142] 0 0
Bielsko-Biala
Country [143] 0 0
Poland
State/province [143] 0 0
Bytom
Country [144] 0 0
Poland
State/province [144] 0 0
Chrzanow
Country [145] 0 0
Poland
State/province [145] 0 0
Dabrowa Gornicza
Country [146] 0 0
Poland
State/province [146] 0 0
Gdynia
Country [147] 0 0
Poland
State/province [147] 0 0
Grodzisk Mazowiecki
Country [148] 0 0
Poland
State/province [148] 0 0
Inowroclaw
Country [149] 0 0
Poland
State/province [149] 0 0
Kedzierzyn-Kozle
Country [150] 0 0
Poland
State/province [150] 0 0
Kielce
Country [151] 0 0
Poland
State/province [151] 0 0
Koszalin
Country [152] 0 0
Poland
State/province [152] 0 0
Krakow
Country [153] 0 0
Poland
State/province [153] 0 0
Lodz
Country [154] 0 0
Poland
State/province [154] 0 0
Nowy Targ
Country [155] 0 0
Poland
State/province [155] 0 0
Nysa
Country [156] 0 0
Poland
State/province [156] 0 0
Oswiecim
Country [157] 0 0
Poland
State/province [157] 0 0
Polanica Zdroj
Country [158] 0 0
Poland
State/province [158] 0 0
Pulawy
Country [159] 0 0
Poland
State/province [159] 0 0
Tychy
Country [160] 0 0
Poland
State/province [160] 0 0
Warszawa
Country [161] 0 0
Poland
State/province [161] 0 0
Wloclawek
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Barnaul
Country [163] 0 0
Russian Federation
State/province [163] 0 0
Chita
Country [164] 0 0
Russian Federation
State/province [164] 0 0
Ekaterinburg
Country [165] 0 0
Russian Federation
State/province [165] 0 0
Ivanovo
Country [166] 0 0
Russian Federation
State/province [166] 0 0
Kaliningrad
Country [167] 0 0
Russian Federation
State/province [167] 0 0
Kemerovo
Country [168] 0 0
Russian Federation
State/province [168] 0 0
Krasnodar
Country [169] 0 0
Russian Federation
State/province [169] 0 0
Krasnoyarsk
Country [170] 0 0
Russian Federation
State/province [170] 0 0
Moscow
Country [171] 0 0
Russian Federation
State/province [171] 0 0
Nizhniy Novgorod
Country [172] 0 0
Russian Federation
State/province [172] 0 0
Orenburg
Country [173] 0 0
Russian Federation
State/province [173] 0 0
Penza
Country [174] 0 0
Russian Federation
State/province [174] 0 0
Perm
Country [175] 0 0
Russian Federation
State/province [175] 0 0
Rostov On Don
Country [176] 0 0
Russian Federation
State/province [176] 0 0
Saint Petersburg
Country [177] 0 0
Russian Federation
State/province [177] 0 0
Samara
Country [178] 0 0
Russian Federation
State/province [178] 0 0
Syktyvkar
Country [179] 0 0
Russian Federation
State/province [179] 0 0
Tyumen
Country [180] 0 0
Spain
State/province [180] 0 0
A Coruña
Country [181] 0 0
Spain
State/province [181] 0 0
Almería
Country [182] 0 0
Spain
State/province [182] 0 0
Barcelona
Country [183] 0 0
Spain
State/province [183] 0 0
Madrid
Country [184] 0 0
Spain
State/province [184] 0 0
Murcia
Country [185] 0 0
Spain
State/province [185] 0 0
Málaga
Country [186] 0 0
Spain
State/province [186] 0 0
Sant Boi De Llobregat
Country [187] 0 0
Spain
State/province [187] 0 0
Tarragona
Country [188] 0 0
Spain
State/province [188] 0 0
Ávila
Country [189] 0 0
Sweden
State/province [189] 0 0
Falun
Country [190] 0 0
Sweden
State/province [190] 0 0
Jönköping
Country [191] 0 0
Sweden
State/province [191] 0 0
Linköping
Country [192] 0 0
Sweden
State/province [192] 0 0
Lund
Country [193] 0 0
Sweden
State/province [193] 0 0
Stockholm
Country [194] 0 0
Sweden
State/province [194] 0 0
Sundsvall
Country [195] 0 0
Sweden
State/province [195] 0 0
Uppsala
Country [196] 0 0
Sweden
State/province [196] 0 0
Örebro
Country [197] 0 0
Sweden
State/province [197] 0 0
Östersund
Country [198] 0 0
Turkey
State/province [198] 0 0
Adana
Country [199] 0 0
Turkey
State/province [199] 0 0
Ankara
Country [200] 0 0
Turkey
State/province [200] 0 0
Aydin
Country [201] 0 0
Turkey
State/province [201] 0 0
Bursa
Country [202] 0 0
Turkey
State/province [202] 0 0
Diyarbakir
Country [203] 0 0
Turkey
State/province [203] 0 0
Eskisehir
Country [204] 0 0
Turkey
State/province [204] 0 0
Istanbul
Country [205] 0 0
Turkey
State/province [205] 0 0
Kahramanmaras
Country [206] 0 0
Turkey
State/province [206] 0 0
Kocaeli
Country [207] 0 0
Turkey
State/province [207] 0 0
Konya
Country [208] 0 0
Turkey
State/province [208] 0 0
Sivas
Country [209] 0 0
Ukraine
State/province [209] 0 0
Cherkasy
Country [210] 0 0
Ukraine
State/province [210] 0 0
Dnipropetrovsk
Country [211] 0 0
Ukraine
State/province [211] 0 0
Kharkiv
Country [212] 0 0
Ukraine
State/province [212] 0 0
Kyiv
Country [213] 0 0
Ukraine
State/province [213] 0 0
Lutsk
Country [214] 0 0
Ukraine
State/province [214] 0 0
Lviv
Country [215] 0 0
Ukraine
State/province [215] 0 0
Odesa
Country [216] 0 0
Ukraine
State/province [216] 0 0
Ternopil
Country [217] 0 0
Ukraine
State/province [217] 0 0
Zaporizhzhia
Country [218] 0 0
Ukraine
State/province [218] 0 0
Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Duke Clinical Research Institute
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Harvard Medical School (HMS and HSDM)
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction \[STEMI\] and non-ST-segment elevation acute coronary syndrome \[NSTE-ACS\]).
Trial website
https://clinicaltrials.gov/study/NCT02293395
Trial related presentations / publications
Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.
Povsic TJ, Ohman EM, Roe MT, White J, Rockhold FW, Montalescot G, Cornel JH, Nicolau JC, Steg PG, James S, Bode C, Welsh RC, Plotnikov AN, Mundl H, Gibson CM. P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes. JAMA Cardiol. 2019 Jul 1;4(7):680-684. doi: 10.1001/jamacardio.2019.1510.
Ohman EM, Roe MT, Steg PG, James SK, Povsic TJ, White J, Rockhold F, Plotnikov A, Mundl H, Strony J, Sun X, Husted S, Tendera M, Montalescot G, Bahit MC, Ardissino D, Bueno H, Claeys MJ, Nicolau JC, Cornel JH, Goto S, Kiss RG, Guray U, Park DW, Bode C, Welsh RC, Gibson CM. Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial. Lancet. 2017 May 6;389(10081):1799-1808. doi: 10.1016/S0140-6736(17)30751-1. Epub 2017 Mar 18.
Povsic TJ, Roe MT, Ohman EM, Steg PG, James S, Plotnikov A, Mundl H, Welsh R, Bode C, Gibson CM. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study. Am Heart J. 2016 Apr;174:120-8. doi: 10.1016/j.ahj.2016.01.004. Epub 2016 Jan 18.
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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/NCT02293395