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An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00809965
First received: December 16, 2008
Last updated: August 26, 2014
Last verified: August 2014
Results First Received: May 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Myocardial Ischemia
Unstable Angina
Interventions: Drug: Rivaroxaban 2.5 mg
Drug: Rivaroxaban 5 mg
Drug: Placebo
Drug: Standard of care

  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 in patients with acute coronary syndrome, was conducted between 26 November 2008 and 19 September 2011. Patients were recruited from 766 study centers located in 44 countries worldwide.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 15,526 patients were randomly allocated to the 3 treatment arms in the study. A total of 15,350 patients (5,115 patients in the rivaroxaban 2.5 mg bid group, 5,110 patients in the rivaroxaban 5 mg bid group and 5,125 patients in the placebo group) who received at least 1 dose of study drug were included in the safety analysis set.

Reporting Groups
  Description
Placebo One placebo tablet twice daily
Rivaroxaban 2.5 mg Bid One rivaroxaban 2.5 mg tablet twice daily
Rivaroxaban 5 mg Bid One rivaroxaban 5 mg tablet twice daily

Participant Flow:   Overall Study
    Placebo   Rivaroxaban 2.5 mg Bid   Rivaroxaban 5 mg Bid
STARTED   5176   5174   5176 
Treated/Safety Population   5125 [1]   5115 [1]   5110 [1] 
Modified Intent-to-Treat Population   5113 [2]   5114 [2]   5115 [2] 
COMPLETED   4393   4399   4332 
NOT COMPLETED   783   775   844 
Death                194                147                196 
Lost to Follow-up                17                10                18 
Withdrawal by Subject                405                448                441 
Other Reason                167                170                189 
[1] All randomized participants who received at least one dose of study drug
[2] All randomized participants excluding 3 sites without regard to treatment exposure



  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.
No text entered.

Reporting Groups
  Description
Placebo One placebo tablet twice daily
Rivaroxaban 2.5 mg Bid One rivaroxaban 2.5 mg tablet twice daily
Rivaroxaban 5 mg Bid One rivaroxaban 5 mg tablet twice daily
Total Total of all reporting groups

Baseline Measures
   Placebo   Rivaroxaban 2.5 mg Bid   Rivaroxaban 5 mg Bid   Total 
Overall Participants Analyzed 
[Units: Participants]
 5125   5115   5110   15350 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   3320   3239   3210   9769 
>=65 years   1805   1876   1900   5581 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.5  (9.38)   61.8  (9.22)   61.9  (9.00)   61.7  (9.20) 
Gender 
[Units: Participants]
       
Female   1280   1283   1316   3879 
Male   3845   3832   3794   11471 
Region of Enrollment 
[Units: Participants]
       
Argentina   118   126   158   402 
Australia   172   182   150   504 
Belgium   59   57   53   169 
Brazil   184   171   168   523 
Bulgaria   258   264   268   790 
Canada   67   58   63   188 
Chile   67   65   78   210 
China   281   299   302   882 
Colombia   97   84   87   268 
Croatia   21   19   22   62 
Czech Republic   154   158   170   482 
Denmark   35   21   41   97 
Egypt   63   47   46   156 
France   68   67   72   207 
Germany   101   96   122   319 
Greece   19   21   27   67 
Hungary   147   142   122   411 
India   479   507   473   1459 
Israel   114   122   101   337 
Italy   78   77   77   232 
Japan   131   135   131   397 
Latvia   27   33   40   100 
Lithuania   59   51   66   176 
Malaysia   36   33   26   95 
Mexico   71   96   86   253 
Morocco   12   22   22   56 
Netherlands   131   113   124   368 
New Zealand   28   31   38   97 
Philippines   19   11   8   38 
Poland   332   361   356   1049 
Portugal   36   36   43   115 
Romania   103   94   107   304 
Russian Federation   586   596   569   1751 
Serbia   43   45   29   117 
Slovakia   67   58   53   178 
South Korea   57   40   49   146 
Spain   71   73   76   220 
Sweden   58   41   44   143 
Thailand   52   50   38   140 
Tunisia   60   62   52   174 
Turkey   37   39   41   117 
Ukraine   205   210   213   628 
United Kingdom   79   91   75   245 
United States   243   211   224   678 


  Outcome Measures
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1.  Primary:   The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke   [ Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) ]

2.  Secondary:   The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke   [ Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) ]

3.  Secondary:   The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery   [ Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) ]

4.  Secondary:   The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization   [ Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) ]

5.  Secondary:   The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization   [ Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Development Head Cardiovascular/Urology
Organization: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
phone: 1 215 628-5257


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: NCT00809965     History of Changes
Other Study ID Numbers: CR014710
RIVAROXACS3001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
Study First Received: December 16, 2008
Results First Received: May 5, 2014
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration
Croatia: Ministry of Health and Social Care
Great Britain: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Ukraine: State Pharmacological Center - Ministry of Health