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Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

This study has been completed.
Sponsor:
Collaborator:
Janssen R&D, L.L.C.
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00494871
First received: June 29, 2007
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
Results First Received: March 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Atrial Fibrillation
Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Warfarin
Drug: Rivaroxaban placebo
Drug: Warfarin 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
The first participant entered the study on 08 Jun 2007, and the last participant completed the study on 19 Jan 2010. The study was conducted at 167 centers in Japan. 164 study centers enrolled at least 1 participant.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 1439 participants were screened for study eligibility; 159 participants were screening failures and were not randomized. Therefore, 1280 participants (640 in each group) were randomized.

Reporting Groups
  Description
Rivaroxaban (Xarelto, BAY59-7939) Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
Warfarin Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Participant Flow for 2 periods

 Period 1:   Double-blind (DB) Treatment Period
    Rivaroxaban (Xarelto, BAY59-7939)     Warfarin  
STARTED     640     640  
Started Treatment     639 [1]   639 [1]
COMPLETED     480     468  
NOT COMPLETED     160     172  
Adverse Event                 73                 70  
Withdrawal by Subject                 26                 35  
Death                 8                 3  
Physician Decision                 4                 13  
Lost to Follow-up                 4                 1  
Protocol Violation                 9                 9  
Clinical Endpoint Reached                 18                 28  
Non-compliant with Study Medication                 3                 1  
Protocol Driven Decision Point                 12                 8  
Site Closed by Investigator                 1                 2  
Site Closed by Sponsor                 1                 1  
Drop out before Treatment Start                 1                 1  
[1] Safety population

Period 2:   Follow-up (FU) Period
    Rivaroxaban (Xarelto, BAY59-7939)     Warfarin  
STARTED     639 [1]   639 [1]
Entered FU and Valid for Safety     628 [2]   630 [2]
COMPLETED     610     616  
NOT COMPLETED     29     23  
Adverse Event                 1                 1  
Death                 13                 12  
Lost to Follow-up                 6                 2  
Physician Decision                 0                 1  
Protocol Violation                 1                 0  
Withdrawal by Subject                 5                 5  
Clinical Endpoint Reached                 3                 2  
[1] All treated participants were to enter FU period, whether or not they completed the DB period
[2] Safety population



  Baseline Characteristics
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Reporting Groups
  Description
Rivaroxaban (Xarelto, BAY59-7939) Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
Warfarin Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
Total Total of all reporting groups

Baseline Measures
    Rivaroxaban (Xarelto, BAY59-7939)     Warfarin     Total  
Number of Participants  
[units: participants]
 		  640     640     1280  
Age  
[units: Years]
Mean ± Standard Deviation 		  71.0  ± 8.3     71.2  ± 7.9     71.1  ± 8.1  
Gender  
[units: Participants]
 		     
Female     110     140     250  
Male     530     500     1030  
CL(CR) [creatinine clearance]  
[units: Participants]
 		     
<50 mL/min     141     143     284  
50 to <80 mL/min     329     329     658  
≥80 mL/min     170     168     338  



  Outcome Measures
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1.  Primary:   Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding   [ Time Frame: Up to 2 days after the last dose ]
  Show Outcome Measure 1

2.  Secondary:   Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism   [ Time Frame: Up to 2 days after the last dose ]
  Show Outcome Measure 2

3.  Secondary:   Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death   [ Time Frame: Up to 2 days after the last dose ]
  Show Outcome Measure 3

4.  Secondary:   Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death   [ Time Frame: Up to 2 days after the last dose ]
  Show Outcome Measure 4

5.  Secondary:   Event Rate of Stroke   [ Time Frame: Up to 2 days after the last dose ]
  Show Outcome Measure 5

6.  Secondary:   Event Rate of Non-CNS Systemic Embolism   [ Time Frame: Up to 2 days after the last dose ]
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7.  Secondary:   Event Rate of Myocardial Infarction   [ Time Frame: Up to 2 days after the last dose ]
  Show Outcome Measure 7

8.  Secondary:   Event Rate of Vascular Death   [ Time Frame: Up to 2 days after the last dose ]
  Show Outcome Measure 8

9.  Secondary:   Event Rate of Stroke With Serious Residual Disability   [ Time Frame: Up to 2 days after the last dose ]
  Show Outcome Measure 9

10.  Secondary:   Event Rate of All-cause Death   [ Time Frame: Up to 2 days after the last dose ]
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11.  Secondary:   Event Rate of Adjudicated Major Bleeding   [ Time Frame: Up to 2 days after the last dose ]
  Show Outcome Measure 11

12.  Secondary:   Event Rate Adjudicated Non-major Clinically Relevant Bleeding   [ Time Frame: Up to 2 days after the last dose ]
  Show Outcome Measure 12


  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:


Responsible Party: Therapeutic Area Head, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier: NCT00494871     History of Changes
Other Study ID Numbers: 12620
Study First Received: June 29, 2007
Results First Received: March 28, 2012
Last Updated: March 25, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency