Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00403767     History of Changes
Other Study ID Numbers: CR012157
39039039AFL3001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
ROCKET AF ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
2006-004595-13 ( EudraCT Number )
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