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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00403767




Registration number
NCT00403767
Ethics application status
Date submitted
23/11/2006
Date registered
27/11/2006
Date last updated
29/04/2014

Titles & IDs
Public title
An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
Scientific title
A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation
Secondary ID [1] 0 0
39039039AFL3001
Secondary ID [2] 0 0
CR012157
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
Embolism 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban
Treatment: Drugs - Warfarin
Treatment: Drugs - Matching placebo for Rivaroxaban arm (Warfarin placebo)
Treatment: Drugs - Matching placebo for Warfarin arm (Rivaroxaban placebo)

Experimental: Rivaroxaban -

Active comparator: Warfarin -


Treatment: Drugs: Rivaroxaban
Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years)

Treatment: Drugs: Warfarin
Type=exact number, unit=mg, number=1, 2.5, or 5 mg, form=tablet, route=oral use. Number of warfarin tablets to be determined based on target INR values once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years

Treatment: Drugs: Matching placebo for Rivaroxaban arm (Warfarin placebo)
Form=tablet, route=oral. One warfarin placebo tablet taken orally once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years

Treatment: Drugs: Matching placebo for Warfarin arm (Rivaroxaban placebo)
Form-tablet, Route=oral administration. Number of rivaroxaban placebo determined by the number of warfarin tablets taken. Duration of treatment is up to an expected maximum treatment period of 32 months that may extend up to 4 years
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)
Timepoint [1] 0 0
Up to 4 years
Primary outcome [2] 0 0
The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)
Timepoint [2] 0 0
Up to 4 years
Primary outcome [3] 0 0
The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [1] 0 0
The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
All-cause Mortality
Timepoint [7] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
* Patients must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
* History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Significant mitral stenosis
* Transient atrial fibrillation caused by a reversible disorder
* Active internal bleeding
* Severe disabling stroke
* History of intracranial bleeding
* Hemorrhagic disorders

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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2010
Sample size
Target
Accrual to date
Final
14269
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Auchenflower
Recruitment hospital [3] 0 0
- Bedford Park
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- Box Hill
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- Caboolture
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- Cairns
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- Camperdown
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- Chermside
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- Clayton
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- Coffs Harbour
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- Footscray
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- Garran
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- Geelong
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- Gosford
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- Heidelberg Heights
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- Herston
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- Hobart
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- Joondalup
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- Lismore
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- Liverpool
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- Miranda
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- Nedlands
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- New Lambton Heights
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- Parkville
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- Penrith
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- Prahran
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- Reservoir
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- Southport
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- Windsor
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- Wolloongabba
Recruitment postcode(s) [1] 0 0
- Adelaide
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- Auchenflower
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- Bedford Park
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- Box Hill
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- Chermside
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- Clayton
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- Coffs Harbour
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- Footscray
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- Garran
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- Geelong
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- Gosford
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- Heidelberg Heights
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- Herston
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- Hobart
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- Joondalup
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- Lismore
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- Liverpool
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- Nedlands
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- New Lambton Heights
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- Prahran
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- Reservoir
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- Southport
Recruitment postcode(s) [29] 0 0
- Windsor
Recruitment postcode(s) [30] 0 0
- Wolloongabba
Recruitment outside Australia
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Country [181] 0 0
Czech Republic
State/province [181] 0 0
Praha 5
Country [182] 0 0
Czech Republic
State/province [182] 0 0
Praha 8
Country [183] 0 0
Czech Republic
State/province [183] 0 0
Praha
Country [184] 0 0
Czech Republic
State/province [184] 0 0
Slany
Country [185] 0 0
Czech Republic
State/province [185] 0 0
Svitavy 2
Country [186] 0 0
Czech Republic
State/province [186] 0 0
Svitavy
Country [187] 0 0
Czech Republic
State/province [187] 0 0
Trutnov
Country [188] 0 0
Czech Republic
State/province [188] 0 0
Uherské Hradistì 6
Country [189] 0 0
Czech Republic
State/province [189] 0 0
Zlín 1
Country [190] 0 0
Denmark
State/province [190] 0 0
Esbjerg
Country [191] 0 0
Denmark
State/province [191] 0 0
Frederiksberg
Country [192] 0 0
Denmark
State/province [192] 0 0
Gentofte
Country [193] 0 0
Denmark
State/province [193] 0 0
Hellerup
Country [194] 0 0
Denmark
State/province [194] 0 0
Helsingør
Country [195] 0 0
Denmark
State/province [195] 0 0
Hvidovre
Country [196] 0 0
Denmark
State/province [196] 0 0
Koege
Country [197] 0 0
Denmark
State/province [197] 0 0
København
Country [198] 0 0
Denmark
State/province [198] 0 0
Næstved
Country [199] 0 0
Denmark
State/province [199] 0 0
Roskilde
Country [200] 0 0
Denmark
State/province [200] 0 0
Slagelse
Country [201] 0 0
Denmark
State/province [201] 0 0
Viborg
Country [202] 0 0
Finland
State/province [202] 0 0
Helsinki
Country [203] 0 0
Finland
State/province [203] 0 0
Jyväskylä N/A
Country [204] 0 0
Finland
State/province [204] 0 0
Kuopio
Country [205] 0 0
Finland
State/province [205] 0 0
Mikkeli
Country [206] 0 0
Finland
State/province [206] 0 0
Oulu
Country [207] 0 0
Finland
State/province [207] 0 0
Turku
Country [208] 0 0
France
State/province [208] 0 0
Albi
Country [209] 0 0
France
State/province [209] 0 0
Arras
Country [210] 0 0
France
State/province [210] 0 0
Bayonne
Country [211] 0 0
France
State/province [211] 0 0
Belfort
Country [212] 0 0
France
State/province [212] 0 0
Besancon N/A
Country [213] 0 0
France
State/province [213] 0 0
Bourg En Bresse
Country [214] 0 0
France
State/province [214] 0 0
Brest
Country [215] 0 0
France
State/province [215] 0 0
Béziers Languedoc-Roussillon
Country [216] 0 0
France
State/province [216] 0 0
Carcassonne
Country [217] 0 0
France
State/province [217] 0 0
Clermont Ferrand
Country [218] 0 0
France
State/province [218] 0 0
Corbeil Essonnes
Country [219] 0 0
France
State/province [219] 0 0
Lille
Country [220] 0 0
France
State/province [220] 0 0
Marseille
Country [221] 0 0
France
State/province [221] 0 0
Montbeliard
Country [222] 0 0
France
State/province [222] 0 0
Montpellier
Country [223] 0 0
France
State/province [223] 0 0
Paris Cedex 14
Country [224] 0 0
France
State/province [224] 0 0
Paris
Country [225] 0 0
France
State/province [225] 0 0
Perpignan
Country [226] 0 0
France
State/province [226] 0 0
Poitiers
Country [227] 0 0
France
State/province [227] 0 0
Saint-Brieuc
Country [228] 0 0
France
State/province [228] 0 0
St Jean De Verges
Country [229] 0 0
France
State/province [229] 0 0
Strasbourg
Country [230] 0 0
France
State/province [230] 0 0
Thionville
Country [231] 0 0
France
State/province [231] 0 0
Toulouse
Country [232] 0 0
France
State/province [232] 0 0
Trelivan
Country [233] 0 0
Germany
State/province [233] 0 0
Aalen
Country [234] 0 0
Germany
State/province [234] 0 0
Berlin/Spandau
Country [235] 0 0
Germany
State/province [235] 0 0
Berlin
Country [236] 0 0
Germany
State/province [236] 0 0
Biberach
Country [237] 0 0
Germany
State/province [237] 0 0
Bochum
Country [238] 0 0
Germany
State/province [238] 0 0
Bonn
Country [239] 0 0
Germany
State/province [239] 0 0
Chemnitz
Country [240] 0 0
Germany
State/province [240] 0 0
Coburg
Country [241] 0 0
Germany
State/province [241] 0 0
Dachau
Country [242] 0 0
Germany
State/province [242] 0 0
Dortmund
Country [243] 0 0
Germany
State/province [243] 0 0
Dresden
Country [244] 0 0
Germany
State/province [244] 0 0
Duisburg
Country [245] 0 0
Germany
State/province [245] 0 0
Ebersbach
Country [246] 0 0
Germany
State/province [246] 0 0
Eilenburg
Country [247] 0 0
Germany
State/province [247] 0 0
Erfurt
Country [248] 0 0
Germany
State/province [248] 0 0
Essen
Country [249] 0 0
Germany
State/province [249] 0 0
Frankfurt
Country [250] 0 0
Germany
State/province [250] 0 0
Freiburg
Country [251] 0 0
Germany
State/province [251] 0 0
Greifswald
Country [252] 0 0
Germany
State/province [252] 0 0
Halle
Country [253] 0 0
Germany
State/province [253] 0 0
Hamburg
Country [254] 0 0
Germany
State/province [254] 0 0
Hartmannsdorf
Country [255] 0 0
Germany
State/province [255] 0 0
Heidelberg
Country [256] 0 0
Germany
State/province [256] 0 0
Henstedt-Rhen
Country [257] 0 0
Germany
State/province [257] 0 0
Herford
Country [258] 0 0
Germany
State/province [258] 0 0
Homburg/Saar
Country [259] 0 0
Germany
State/province [259] 0 0
Jena
Country [260] 0 0
Germany
State/province [260] 0 0
Julich
Country [261] 0 0
Germany
State/province [261] 0 0
Kamen
Country [262] 0 0
Germany
State/province [262] 0 0
Karlsbad
Country [263] 0 0
Germany
State/province [263] 0 0
Kassel
Country [264] 0 0
Germany
State/province [264] 0 0
Kirchzarten
Country [265] 0 0
Germany
State/province [265] 0 0
Krefeld
Country [266] 0 0
Germany
State/province [266] 0 0
Leipzig
Country [267] 0 0
Germany
State/province [267] 0 0
Ludwigsburg
Country [268] 0 0
Germany
State/province [268] 0 0
Ludwigshafen
Country [269] 0 0
Germany
State/province [269] 0 0
Lüneburg
Country [270] 0 0
Germany
State/province [270] 0 0
Magdeburg
Country [271] 0 0
Germany
State/province [271] 0 0
Mainz
Country [272] 0 0
Germany
State/province [272] 0 0
Mannheim
Country [273] 0 0
Germany
State/province [273] 0 0
Markkleeberg
Country [274] 0 0
Germany
State/province [274] 0 0
Meißen
Country [275] 0 0
Germany
State/province [275] 0 0
Melsungen
Country [276] 0 0
Germany
State/province [276] 0 0
Monchengladbach
Country [277] 0 0
Germany
State/province [277] 0 0
Munchen
Country [278] 0 0
Germany
State/province [278] 0 0
Mühldorf
Country [279] 0 0
Germany
State/province [279] 0 0
Mülheim
Country [280] 0 0
Germany
State/province [280] 0 0
Münster
Country [281] 0 0
Germany
State/province [281] 0 0
Neuwied
Country [282] 0 0
Germany
State/province [282] 0 0
Nienburg
Country [283] 0 0
Germany
State/province [283] 0 0
Nuernberg
Country [284] 0 0
Germany
State/province [284] 0 0
Paderborn
Country [285] 0 0
Germany
State/province [285] 0 0
Potsdam
Country [286] 0 0
Germany
State/province [286] 0 0
Riesa
Country [287] 0 0
Germany
State/province [287] 0 0
Rottweil
Country [288] 0 0
Germany
State/province [288] 0 0
Sachsen
Country [289] 0 0
Germany
State/province [289] 0 0
Siegen
Country [290] 0 0
Germany
State/province [290] 0 0
Ulm
Country [291] 0 0
Germany
State/province [291] 0 0
Wermsdorf
Country [292] 0 0
Germany
State/province [292] 0 0
Witten
Country [293] 0 0
Germany
State/province [293] 0 0
Wolmirstedt
Country [294] 0 0
Germany
State/province [294] 0 0
Wuppertal
Country [295] 0 0
Greece
State/province [295] 0 0
Athens Attica
Country [296] 0 0
Greece
State/province [296] 0 0
Ioannina
Country [297] 0 0
Greece
State/province [297] 0 0
Maroussi Athens
Country [298] 0 0
Greece
State/province [298] 0 0
Patra
Country [299] 0 0
Greece
State/province [299] 0 0
Piraeus Attica
Country [300] 0 0
Greece
State/province [300] 0 0
Tripoli
Country [301] 0 0
Greece
State/province [301] 0 0
Voula Attica
Country [302] 0 0
Hong Kong
State/province [302] 0 0
Aberdeen
Country [303] 0 0
Hong Kong
State/province [303] 0 0
Hk
Country [304] 0 0
Hong Kong
State/province [304] 0 0
Kln
Country [305] 0 0
Hong Kong
State/province [305] 0 0
Sha Tin
Country [306] 0 0
Hungary
State/province [306] 0 0
Budapest N/A
Country [307] 0 0
Hungary
State/province [307] 0 0
Budapest Nap
Country [308] 0 0
Hungary
State/province [308] 0 0
Budapest
Country [309] 0 0
Hungary
State/province [309] 0 0
Debrecen County
Country [310] 0 0
Hungary
State/province [310] 0 0
Eger
Country [311] 0 0
Hungary
State/province [311] 0 0
Gyongyos
Country [312] 0 0
Hungary
State/province [312] 0 0
Gyõr
Country [313] 0 0
Hungary
State/province [313] 0 0
Kesckemet
Country [314] 0 0
Hungary
State/province [314] 0 0
Miskolc
Country [315] 0 0
Hungary
State/province [315] 0 0
Nyiregyhaza
Country [316] 0 0
Hungary
State/province [316] 0 0
Pecs
Country [317] 0 0
Hungary
State/province [317] 0 0
Szeged
Country [318] 0 0
Hungary
State/province [318] 0 0
Szekszard
Country [319] 0 0
Hungary
State/province [319] 0 0
Szombathely
Country [320] 0 0
Hungary
State/province [320] 0 0
Veszprem
Country [321] 0 0
Hungary
State/province [321] 0 0
Zalaegerszeg
Country [322] 0 0
India
State/province [322] 0 0
Ahmedabad
Country [323] 0 0
India
State/province [323] 0 0
Bangalore
Country [324] 0 0
India
State/province [324] 0 0
Bikaner
Country [325] 0 0
India
State/province [325] 0 0
Chennai
Country [326] 0 0
India
State/province [326] 0 0
Coimbatore
Country [327] 0 0
India
State/province [327] 0 0
Gandhinagar Guiarat
Country [328] 0 0
India
State/province [328] 0 0
Hyderabad Andra Pradesh
Country [329] 0 0
India
State/province [329] 0 0
Hyderabad
Country [330] 0 0
India
State/province [330] 0 0
Jalandhar
Country [331] 0 0
India
State/province [331] 0 0
Madurai
Country [332] 0 0
India
State/province [332] 0 0
Mangalore
Country [333] 0 0
India
State/province [333] 0 0
Mumbai
Country [334] 0 0
India
State/province [334] 0 0
Mysore
Country [335] 0 0
India
State/province [335] 0 0
New Delhi
Country [336] 0 0
India
State/province [336] 0 0
Pune
Country [337] 0 0
India
State/province [337] 0 0
Suraj
Country [338] 0 0
India
State/province [338] 0 0
Vadodara
Country [339] 0 0
India
State/province [339] 0 0
Vishakapatnam
Country [340] 0 0
Israel
State/province [340] 0 0
Afula
Country [341] 0 0
Israel
State/province [341] 0 0
Ashkelon
Country [342] 0 0
Israel
State/province [342] 0 0
Hadera
Country [343] 0 0
Israel
State/province [343] 0 0
Haifa
Country [344] 0 0
Israel
State/province [344] 0 0
Holon
Country [345] 0 0
Israel
State/province [345] 0 0
Jerusalem
Country [346] 0 0
Israel
State/province [346] 0 0
Nazareth
Country [347] 0 0
Israel
State/province [347] 0 0
Netanya
Country [348] 0 0
Israel
State/province [348] 0 0
Petach-Tikva
Country [349] 0 0
Israel
State/province [349] 0 0
Petah-Tikva
Country [350] 0 0
Israel
State/province [350] 0 0
Poriya
Country [351] 0 0
Israel
State/province [351] 0 0
Rehovot
Country [352] 0 0
Israel
State/province [352] 0 0
Safed
Country [353] 0 0
Israel
State/province [353] 0 0
Tel Aviv
Country [354] 0 0
Israel
State/province [354] 0 0
Tel Hashomer
Country [355] 0 0
Israel
State/province [355] 0 0
Zerifin
Country [356] 0 0
Korea, Republic of
State/province [356] 0 0
Anyang
Country [357] 0 0
Korea, Republic of
State/province [357] 0 0
Daegu
Country [358] 0 0
Korea, Republic of
State/province [358] 0 0
Daejeon
Country [359] 0 0
Korea, Republic of
State/province [359] 0 0
Goyang
Country [360] 0 0
Korea, Republic of
State/province [360] 0 0
Kyonggi-Do
Country [361] 0 0
Korea, Republic of
State/province [361] 0 0
Pusan
Country [362] 0 0
Korea, Republic of
State/province [362] 0 0
Seoul
Country [363] 0 0
Korea, Republic of
State/province [363] 0 0
Sungnam
Country [364] 0 0
Korea, Republic of
State/province [364] 0 0
Suwon
Country [365] 0 0
Lithuania
State/province [365] 0 0
Kaunas
Country [366] 0 0
Lithuania
State/province [366] 0 0
Klaipeda
Country [367] 0 0
Lithuania
State/province [367] 0 0
Panevezys
Country [368] 0 0
Lithuania
State/province [368] 0 0
Siauliai
Country [369] 0 0
Lithuania
State/province [369] 0 0
Vilnius
Country [370] 0 0
Malaysia
State/province [370] 0 0
Kelantan
Country [371] 0 0
Malaysia
State/province [371] 0 0
Kuala Lumpur
Country [372] 0 0
Malaysia
State/province [372] 0 0
Sarawak
Country [373] 0 0
Mexico
State/province [373] 0 0
Aguascalientes
Country [374] 0 0
Mexico
State/province [374] 0 0
Ciudad De Mexico
Country [375] 0 0
Mexico
State/province [375] 0 0
Culiacán Sinaloa/Mèxico
Country [376] 0 0
Mexico
State/province [376] 0 0
Guadalajara
Country [377] 0 0
Mexico
State/province [377] 0 0
Hermosillo
Country [378] 0 0
Mexico
State/province [378] 0 0
Monterrey Nuevo Leòn
Country [379] 0 0
Mexico
State/province [379] 0 0
Monterrey
Country [380] 0 0
Mexico
State/province [380] 0 0
Queretaro
Country [381] 0 0
Mexico
State/province [381] 0 0
San Luis Potosi
Country [382] 0 0
Mexico
State/province [382] 0 0
Sinaloa
Country [383] 0 0
Mexico
State/province [383] 0 0
Zapopan
Country [384] 0 0
Netherlands
State/province [384] 0 0
'S-Gravenhage
Country [385] 0 0
Netherlands
State/province [385] 0 0
Alkmaar
Country [386] 0 0
Netherlands
State/province [386] 0 0
Amersfoort
Country [387] 0 0
Netherlands
State/province [387] 0 0
Amsterdam
Country [388] 0 0
Netherlands
State/province [388] 0 0
Blaricum
Country [389] 0 0
Netherlands
State/province [389] 0 0
Delft
Country [390] 0 0
Netherlands
State/province [390] 0 0
Den Bosch
Country [391] 0 0
Netherlands
State/province [391] 0 0
Den Haag
Country [392] 0 0
Netherlands
State/province [392] 0 0
Gc Tilburg
Country [393] 0 0
Netherlands
State/province [393] 0 0
Gouda
Country [394] 0 0
Netherlands
State/province [394] 0 0
Groningen
Country [395] 0 0
Netherlands
State/province [395] 0 0
Haarlem
Country [396] 0 0
Netherlands
State/province [396] 0 0
Heerlen
Country [397] 0 0
Netherlands
State/province [397] 0 0
Hoofddorp
Country [398] 0 0
Netherlands
State/province [398] 0 0
Hoorn Nh
Country [399] 0 0
Netherlands
State/province [399] 0 0
Leeuwarden
Country [400] 0 0
Netherlands
State/province [400] 0 0
Leidschendam
Country [401] 0 0
Netherlands
State/province [401] 0 0
Maastricht
Country [402] 0 0
Netherlands
State/province [402] 0 0
Meppel
Country [403] 0 0
Netherlands
State/province [403] 0 0
Nijmegen
Country [404] 0 0
Netherlands
State/province [404] 0 0
Schiedam
Country [405] 0 0
Netherlands
State/province [405] 0 0
Veldhoven
Country [406] 0 0
New Zealand
State/province [406] 0 0
Christchurch
Country [407] 0 0
New Zealand
State/province [407] 0 0
Dunedin
Country [408] 0 0
New Zealand
State/province [408] 0 0
Grafton
Country [409] 0 0
New Zealand
State/province [409] 0 0
Hamilton
Country [410] 0 0
New Zealand
State/province [410] 0 0
Takapuna Auckland
Country [411] 0 0
New Zealand
State/province [411] 0 0
Wellington
Country [412] 0 0
Norway
State/province [412] 0 0
Alesund
Country [413] 0 0
Norway
State/province [413] 0 0
Bergen
Country [414] 0 0
Norway
State/province [414] 0 0
Elverum
Country [415] 0 0
Norway
State/province [415] 0 0
Hamar
Country [416] 0 0
Norway
State/province [416] 0 0
Jessheim
Country [417] 0 0
Norway
State/province [417] 0 0
Lillehammer
Country [418] 0 0
Norway
State/province [418] 0 0
Moss
Country [419] 0 0
Norway
State/province [419] 0 0
Oslo
Country [420] 0 0
Norway
State/province [420] 0 0
Sandefjord
Country [421] 0 0
Norway
State/province [421] 0 0
Sandnes
Country [422] 0 0
Norway
State/province [422] 0 0
Sandvika
Country [423] 0 0
Norway
State/province [423] 0 0
Skedsmokorset
Country [424] 0 0
Peru
State/province [424] 0 0
L41 Lima Lima
Country [425] 0 0
Peru
State/province [425] 0 0
Lima 1 Lima Lima
Country [426] 0 0
Peru
State/province [426] 0 0
Lima
Country [427] 0 0
Philippines
State/province [427] 0 0
Cebuu City
Country [428] 0 0
Philippines
State/province [428] 0 0
Davao City
Country [429] 0 0
Philippines
State/province [429] 0 0
Iloilo City
Country [430] 0 0
Philippines
State/province [430] 0 0
Manila City
Country [431] 0 0
Philippines
State/province [431] 0 0
Quezon City
Country [432] 0 0
Poland
State/province [432] 0 0
Bydgoszcz N/A
Country [433] 0 0
Poland
State/province [433] 0 0
Bydgoszcz
Country [434] 0 0
Poland
State/province [434] 0 0
Gdansk
Country [435] 0 0
Poland
State/province [435] 0 0
Gdynia
Country [436] 0 0
Poland
State/province [436] 0 0
Katowice-Ochojec
Country [437] 0 0
Poland
State/province [437] 0 0
Katowice
Country [438] 0 0
Poland
State/province [438] 0 0
Krakow
Country [439] 0 0
Poland
State/province [439] 0 0
Lodz
Country [440] 0 0
Poland
State/province [440] 0 0
Olawa
Country [441] 0 0
Poland
State/province [441] 0 0
Olsztyn
Country [442] 0 0
Poland
State/province [442] 0 0
Opole
Country [443] 0 0
Poland
State/province [443] 0 0
Ostrowiec N/A
Country [444] 0 0
Poland
State/province [444] 0 0
Piotrkow Trybunalski
Country [445] 0 0
Poland
State/province [445] 0 0
Plock
Country [446] 0 0
Poland
State/province [446] 0 0
Poznan
Country [447] 0 0
Poland
State/province [447] 0 0
Siedlce
Country [448] 0 0
Poland
State/province [448] 0 0
Sieradz N/A
Country [449] 0 0
Poland
State/province [449] 0 0
Skierniewice
Country [450] 0 0
Poland
State/province [450] 0 0
Starogard Gdanski Nap
Country [451] 0 0
Poland
State/province [451] 0 0
Szczecin Nap
Country [452] 0 0
Poland
State/province [452] 0 0
Szczecin
Country [453] 0 0
Poland
State/province [453] 0 0
Torun
Country [454] 0 0
Poland
State/province [454] 0 0
Warsaw
Country [455] 0 0
Poland
State/province [455] 0 0
Warszawa N/A
Country [456] 0 0
Poland
State/province [456] 0 0
Warszawa
Country [457] 0 0
Poland
State/province [457] 0 0
Wloclawek
Country [458] 0 0
Poland
State/province [458] 0 0
Wroclaw N/A
Country [459] 0 0
Poland
State/province [459] 0 0
Wroclaw
Country [460] 0 0
Poland
State/province [460] 0 0
Zyrardow N/A
Country [461] 0 0
Romania
State/province [461] 0 0
Brasov
Country [462] 0 0
Romania
State/province [462] 0 0
Bucharest
Country [463] 0 0
Romania
State/province [463] 0 0
Bucuresti
Country [464] 0 0
Romania
State/province [464] 0 0
Craiova
Country [465] 0 0
Romania
State/province [465] 0 0
Focsani
Country [466] 0 0
Romania
State/province [466] 0 0
Iasi
Country [467] 0 0
Romania
State/province [467] 0 0
Oradea
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Suceava
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Kemerovo
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Russian Federation
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Krasnoyarsk
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Moscow N/A
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Russian Federation
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Moscow
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Russian Federation
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Nizhni Novgorod
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Russian Federation
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Novosibirsk Nap
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint-Petersburg
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Smolensk
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St Petersburg
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Russian Federation
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St. Petersburg
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Tomsk
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Russian Federation
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Tyumen Tyumen Region
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Russian Federation
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Yaroslavl Nap
Country [495] 0 0
Russian Federation
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Yaroslavl
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Singapore
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Singapore
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Cape Town Western Cape
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Cape Town
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Durban Kwa Zulu Natal
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South Africa
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Johannesburg Gauteng
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South Africa
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Kempton Park Gauteng
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South Africa
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Port Elizabeth Eastern Cape
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South Africa
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Pretoria Gauteng
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South Africa
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A Coruna
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Almeria
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Barcelona
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Burgos
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Taipei
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Taiwan
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Tamshui
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Taiwan
State/province [545] 0 0
Tao-Yuan
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Thailand
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Bangkok Noi
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Görükle
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Izmir
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Kayseri
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Turkey
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Konya
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Turkey
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Malatya Nap
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Turkey
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Mersin
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Turkey
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Samsun
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Ukraine
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Sumy
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Dundee
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Glasgow
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United Kingdom
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Harrogate
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Hull
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Lincoln
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Liverpool
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Nottingham
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Plymouth
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Romford
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Sheffield
Country [613] 0 0
United Kingdom
State/province [613] 0 0
Stirling
Country [614] 0 0
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State/province [614] 0 0
Stoke On Trent
Country [615] 0 0
United Kingdom
State/province [615] 0 0
York
Country [616] 0 0
Venezuela
State/province [616] 0 0
Caracas
Country [617] 0 0
Venezuela
State/province [617] 0 0
Maracaibo Estado Zulia
Country [618] 0 0
Venezuela
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Maracay Estado Aragua

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).
Trial website
https://clinicaltrials.gov/study/NCT00403767
Trial related presentations / publications
Ungar L, Rodriguez F, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Patel MR, Piccini JP, Mahaffey KW. Patient-Reported Satisfaction and Study Drug Discontinuation: Post-Hoc Analysis of Findings from ROCKET AF. Cardiol Ther. 2019 Dec;8(2):283-295. doi: 10.1007/s40119-019-00146-6. Epub 2019 Aug 2.
Quinn GR, Hellkamp AS, Hankey GJ, Becker RC, Berkowitz SD, Breithardt G, Fava M, Fox KAA, Halperin JL, Mahaffey KW, Nessel CC, Patel MR, Piccini JP, Singer DE. Selective Serotonin Reuptake Inhibitors and Bleeding Risk in Anticoagulated Patients With Atrial Fibrillation: An Analysis From the ROCKET AF Trial. J Am Heart Assoc. 2018 Aug 7;7(15):e008755. doi: 10.1161/JAHA.118.008755.
Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR, Melloni C. Efficacy and safety of rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation and a history of cancer: observations from ROCKET AF. Eur Heart J Qual Care Clin Outcomes. 2019 Apr 1;5(2):145-152. doi: 10.1093/ehjqcco/qcy040.
Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR. Impact of polyvascular disease on patients with atrial fibrillation: Insights from ROCKET AF. Am Heart J. 2018 Jun;200:102-109. doi: 10.1016/j.ahj.2018.02.013. Epub 2018 Feb 27.
Leef GC, Hellkamp AS, Patel MR, Becker RC, Berkowitz SD, Breithardt G, Halperin JL, Hankey GJ, Hacke W, Nessel CC, Singer DE, Fox KAA, Mahaffey KW, Piccini JP. Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial. J Am Heart Assoc. 2017 Jun 14;6(6):e004663. doi: 10.1161/JAHA.116.004663.
Balla SR, Cyr DD, Lokhnygina Y, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR. Relation of Risk of Stroke in Patients With Atrial Fibrillation to Body Mass Index (from Patients Treated With Rivaroxaban and Warfarin in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation Trial). Am J Cardiol. 2017 Jun 15;119(12):1989-1996. doi: 10.1016/j.amjcard.2017.03.028. Epub 2017 Mar 29.
Sun Y, Hu D, Stevens S, Lokhnygina Y, Becker RC, Berkowitz SD, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Fox KAA, Patel MR. Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation: A subgroup analysis from the ROCKET AF trial. Thromb Res. 2017 Aug;156:184-190. doi: 10.1016/j.thromres.2017.04.010. Epub 2017 Apr 13.
Lindner SM, Fordyce CB, Hellkamp AS, Lokhnygina Y, Piccini JP, Breithardt G, Mahaffey KW, Singer DE, Hacke W, Halperin JL, Hankey GJ, Berkowitz SD, Nessel CC, Becker RC, Fox KA, Patel MR; ROCKET AF Steering Committee and Investigators. Treatment Consistency Across Levels of Baseline Renal Function With Rivaroxaban or Warfarin: A ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) Analysis. Circulation. 2017 Mar 7;135(10):1001-1003. doi: 10.1161/CIRCULATIONAHA.116.024666. No abstract available.
Fordyce CB, Hellkamp AS, Lokhnygina Y, Lindner SM, Piccini JP, Becker RC, Berkowitz SD, Breithardt G, Fox KA, Mahaffey KW, Nessel CC, Singer DE, Patel MR; ROCKET AF Steering Committee and Investigators. On-Treatment Outcomes in Patients With Worsening Renal Function With Rivaroxaban Compared With Warfarin: Insights From ROCKET AF. Circulation. 2016 Jul 5;134(1):37-47. doi: 10.1161/CIRCULATIONAHA.116.021890. Erratum In: Circulation. 2016 Aug 23;134(8):e114. doi: 10.1161/CIR.0000000000000451. Circulation. 2020 Feb 25;141(8):e98. doi: 10.1161/CIR.0000000000000763.
Pokorney SD, Piccini JP, Stevens SR, Patel MR, Pieper KS, Halperin JL, Breithardt G, Singer DE, Hankey GJ, Hacke W, Becker RC, Berkowitz SD, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Steering Committee & Investigators; ROCKET AF Steering Committee Investigators. Cause of Death and Predictors of All-Cause Mortality in Anticoagulated Patients With Nonvalvular Atrial Fibrillation: Data From ROCKET AF. J Am Heart Assoc. 2016 Mar 8;5(3):e002197. doi: 10.1161/JAHA.115.002197.
Breithardt G, Baumgartner H, Berkowitz SD, Hellkamp AS, Piccini JP, Lokhnygina Y, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Califf RM, Fox KA, Patel MR; ROCKET AF Steering Committee & Investigators. Native valve disease in patients with non-valvular atrial fibrillation on warfarin or rivaroxaban. Heart. 2016 Jul 1;102(13):1036-43. doi: 10.1136/heartjnl-2015-308120. Epub 2016 Feb 17.
Piccini JP, Hellkamp AS, Washam JB, Becker RC, Breithardt G, Berkowitz SD, Halperin JL, Hankey GJ, Hacke W, Mahaffey KW, Nessel CC, Singer DE, Fox KA, Patel MR. Polypharmacy and the Efficacy and Safety of Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation. Circulation. 2016 Jan 26;133(4):352-60. doi: 10.1161/CIRCULATIONAHA.115.018544. Epub 2015 Dec 16.
Bansilal S, Bloomgarden Z, Halperin JL, Hellkamp AS, Lokhnygina Y, Patel MR, Becker RC, Breithardt G, Hacke W, Hankey GJ, Nessel CC, Singer DE, Berkowitz SD, Piccini JP, Mahaffey KW, Fox KA; ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: the Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF Trial). Am Heart J. 2015 Oct;170(4):675-682.e8. doi: 10.1016/j.ahj.2015.07.006. Epub 2015 Jul 17.
Washam JB, Stevens SR, Lokhnygina Y, Halperin JL, Breithardt G, Singer DE, Mahaffey KW, Hankey GJ, Berkowitz SD, Nessel CC, Fox KA, Califf RM, Piccini JP, Patel MR; ROCKET AF Steering Committee and Investigators. Digoxin use in patients with atrial fibrillation and adverse cardiovascular outcomes: a retrospective analysis of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Lancet. 2015 Jun 13;385(9985):2363-70. doi: 10.1016/S0140-6736(14)61836-5. Epub 2015 Mar 6.
Singer DE, Hellkamp AS, Yuan Z, Lokhnygina Y, Patel MR, Piccini JP, Hankey GJ, Breithardt G, Halperin JL, Becker RC, Hacke W, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Investigators. Alternative calculations of individual patient time in therapeutic range while taking warfarin: results from the ROCKET AF trial. J Am Heart Assoc. 2015 Mar 3;4(3):e001349. doi: 10.1161/JAHA.114.001349.
Girgis IG, Patel MR, Peters GR, Moore KT, Mahaffey KW, Nessel CC, Halperin JL, Califf RM, Fox KA, Becker RC. Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with non-valvular atrial fibrillation: results from ROCKET AF. J Clin Pharmacol. 2014 Aug;54(8):917-27. doi: 10.1002/jcph.288. Epub 2014 Mar 26.
Sherwood MW, Douketis JD, Patel MR, Piccini JP, Hellkamp AS, Lokhnygina Y, Spyropoulos AC, Hankey GJ, Singer DE, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Becker RC; ROCKET AF Investigators. Outcomes of temporary interruption of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: results from the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF). Circulation. 2014 May 6;129(18):1850-9. doi: 10.1161/CIRCULATIONAHA.113.005754. Epub 2014 Feb 19.
Goodman SG, Wojdyla DM, Piccini JP, White HD, Paolini JF, Nessel CC, Berkowitz SD, Mahaffey KW, Patel MR, Sherwood MW, Becker RC, Halperin JL, Hacke W, Singer DE, Hankey GJ, Breithardt G, Fox KA, Califf RM; ROCKET AF Investigators. Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation). J Am Coll Cardiol. 2014 Mar 11;63(9):891-900. doi: 10.1016/j.jacc.2013.11.013. Epub 2013 Dec 4.
Mahaffey KW, Wojdyla D, Hankey GJ, White HD, Nessel CC, Piccini JP, Patel MR, Berkowitz SD, Becker RC, Halperin JL, Singer DE, Califf RM, Fox KA, Breithardt G, Hacke W. Clinical outcomes with rivaroxaban in patients transitioned from vitamin K antagonist therapy: a subgroup analysis of a randomized trial. Ann Intern Med. 2013 Jun 18;158(12):861-8. doi: 10.7326/0003-4819-158-12-201306180-00003.
van Diepen S, Hellkamp AS, Patel MR, Becker RC, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Berkowitz SD, Califf RM, Fox KA, Mahaffey KW. Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circ Heart Fail. 2013 Jul;6(4):740-7. doi: 10.1161/CIRCHEARTFAILURE.113.000212. Epub 2013 May 30.
Singer DE, Hellkamp AS, Piccini JP, Mahaffey KW, Lokhnygina Y, Pan G, Halperin JL, Becker RC, Breithardt G, Hankey GJ, Hacke W, Nessel CC, Patel MR, Califf RM, Fox KA; ROCKET AF Investigators. Impact of global geographic region on time in therapeutic range on warfarin anticoagulant therapy: data from the ROCKET AF clinical trial. J Am Heart Assoc. 2013 Feb 19;2(1):e000067. doi: 10.1161/JAHA.112.000067.
Piccini JP, Stevens SR, Lokhnygina Y, Patel MR, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Breithardt G; ROCKET AF Steering Committee & Investigators. Outcomes after cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF trial. J Am Coll Cardiol. 2013 May 14;61(19):1998-2006. doi: 10.1016/j.jacc.2013.02.025. Epub 2013 Mar 14.
Piccini JP, Stevens SR, Chang Y, Singer DE, Lokhnygina Y, Go AS, Patel MR, Mahaffey KW, Halperin JL, Breithardt G, Hankey GJ, Hacke W, Becker RC, Nessel CC, Fox KA, Califf RM; ROCKET AF Steering Committee and Investigators. Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R(2)CHADS(2) index in the ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation) study cohorts. Circulation. 2013 Jan 15;127(2):224-32. doi: 10.1161/CIRCULATIONAHA.112.107128. Epub 2012 Dec 3.
Hankey GJ, Patel MR, Stevens SR, Becker RC, Breithardt G, Carolei A, Diener HC, Donnan GA, Halperin JL, Mahaffey KW, Mas JL, Massaro A, Norrving B, Nessel CC, Paolini JF, Roine RO, Singer DE, Wong L, Califf RM, Fox KA, Hacke W; ROCKET AF Steering Committee Investigators. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012 Apr;11(4):315-22. doi: 10.1016/S1474-4422(12)70042-X. Epub 2012 Mar 7.
Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010 Mar;159(3):340-347.e1. doi: 10.1016/j.ahj.2009.11.025.
Public notes

Contacts
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00403767