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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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00403767
First received: November 23, 2006
Last updated: April 10, 2014
Last verified: April 2014
Results First Received: December 2, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Atrial Fibrillation
Stroke
Embolism
Interventions: Drug: Rivaroxaban
Drug: Warfarin
Drug: Matching placebo for Rivaroxaban arm (Warfarin placebo)
Drug: Matching placebo for Warfarin arm (Rivaroxaban placebo)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study, 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, was conducted from 18 December 2006 to 07 September 2010. Patients were recruited at 1,170 study centers located in 45 countries worldwide.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 14,269 patients were randomized in the study. Five patients were randomized twice bringing the number of randomized unique patients to 14,264. A total of 14,236 (7111 and 7125 patients in the rivaroxaban and warfarin groups, respectively) unique patients took at least 1 dose of study medication and were included in the Safety Population.

Reporting Groups
  Description
Rivaroxaban Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
Warfarin Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)

Participant Flow:   Overall Study
    Rivaroxaban     Warfarin  
STARTED     7111     7125  
COMPLETED     4591     4657  
NOT COMPLETED     2520     2468  
Adverse Event                 993                 919  
Non-compliant with study medication                 134                 164  
Consent withdrawn                 671                 673  
Investigator dec./not protocol-related                 191                 178  
Lost to Follow-up                 6                 8  
Protocol Violation                 142                 124  
Clinical efficacy endpoint reached                 300                 332  
Study terminated by sponsor                 82                 69  
Missing/incomplete data                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Rivaroxaban Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
Warfarin Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
Total Total of all reporting groups

Baseline Measures
    Rivaroxaban     Warfarin     Total  
Number of Participants  
[units: participants]
  7111     7125     14236  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1646     1642     3288  
>=65 years     5465     5483     10948  
Age  
[units: years]
Mean ± Standard Deviation
     
Age Continuous     71.2  ± 9.45     71.2  ± 9.39     71.2  ± 9.42  
Gender  
[units: participants]
     
Female     2819     2826     5645  
Male     4292     4299     8591  
Region of Enrollment  
[units: participants]
     
Argentina     284     285     569  
Australia     120     122     242  
Austria     16     16     32  
Belgium     49     47     96  
Brazil     241     242     483  
Bulgaria     337     339     676  
Canada     372     375     747  
Chile     144     142     286  
China     249     246     495  
Colombia     134     133     267  
Czech Republic     299     299     598  
Denmark     60     61     121  
Finland     9     7     16  
France     35     36     71  
Germany     263     265     528  
Greece     15     14     29  
Hungary     119     118     237  
India     133     135     268  
Israel     94     94     188  
Italy     69     69     138  
Korea (South)     103     100     203  
Lithuania     122     122     244  
Malaysia     26     25     51  
Mexico     83     85     168  
Netherlands     80     81     161  
New Zealand     58     58     116  
Norway     25     24     49  
Peru     42     42     84  
Philippines     185     183     368  
Poland     263     264     527  
Romania     391     391     782  
Russia     645     645     1290  
Singapore     21     23     44  
South Africa     122     125     247  
Spain     124     124     248  
Sweden     12     16     28  
Switzerland     3     4     7  
Taiwan     78     79     157  
Thailand     43     44     87  
Turkey     50     51     101  
Ukraine     505     504     1009  
United Kingdom     79     80     159  
United States     962     964     1926  
Venezuela     11     9     20  
Hong Kong     36     37     73  



  Outcome Measures
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1.  Primary:   The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)   [ Time Frame: Up to 4 years ]

2.  Primary:   The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)   [ Time Frame: Up to 4 years ]

3.  Primary:   The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety   [ Time Frame: Up to 4 years ]

4.  Secondary:   The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death   [ Time Frame: Up to 4 years ]

5.  Secondary:   The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death   [ Time Frame: Up to 4 years ]

6.  Secondary:   The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke   [ Time Frame: Up to 4 years ]

7.  Secondary:   The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism   [ Time Frame: Up to 4 years ]

8.  Secondary:   The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction   [ Time Frame: Up to 4 years ]

9.  Secondary:   The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death   [ Time Frame: Up to 4 years ]

10.  Secondary:   All-cause Mortality   [ Time Frame: Up to 4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Head of Development, CV & UROL
Organization: Johnson & Johnson Pharmaceutical Research & Development L.L.C.
phone: 1 908-927-7767


No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications automatically indexed to this study:


Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00403767     History of Changes
Other Study ID Numbers: CR012157, 39039039AFL3001, ROCKET AF, 2006-004595-13
Study First Received: November 23, 2006
Results First Received: December 2, 2011
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration