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: May 5, 2014
Last verified: May 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     5125     5115     5110  
COMPLETED     4379     4391     4322  
NOT COMPLETED     746     724     788  
Death                 193                 144                 194  
Lost to Follow-up                 17                 10                 18  
Withdrawal by Subject                 381                 406                 399  
Other Reason                 155                 164                 177  



  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  
Number of Participants  
[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
No text entered.


  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


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: NCT00809965     History of Changes
Other Study ID Numbers: CR014710, RIVAROXACS3001
Study First Received: December 16, 2008
Results First Received: May 5, 2014
Last Updated: May 5, 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