Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737)

This study has been completed.
Sponsor:
Collaborator:
The Thrombolysis in Myocardial Infarction Study (TIMI) Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00526474
First received: September 6, 2007
Last updated: May 16, 2014
Last verified: May 2014
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Atherosclerosis
Ischemia
Myocardial Infarction
Cerebrovascular Accident
Peripheral Arterial Disease
Interventions: Drug: Vorapaxar
Drug: 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
Prior to planned study completion, the Data Safety Monitoring Board (DSMB) recommended discontinuation of study drug in all participants with a pre- or post-randomization history of stroke. A total of 4510 participants had study medication stopped, however these participants were included in the overall population for efficacy and safety analyses.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Intent to Treat (ITT) Population, defined as all enrolled participants who were randomly assigned to a treatment group.

Reporting Groups
  Description
Placebo 1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Vorapaxar one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Participant Flow:   Overall Study
    Placebo     Vorapaxar  
STARTED     13224     13225  
Received Study Drug     13166     13186  
COMPLETED     12932     12953  
NOT COMPLETED     292     272  



  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.
The Intent to Treat (ITT) Population, defined as all enrolled participants who were randomly assigned to a treatment group.

Reporting Groups
  Description
Placebo 1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Vorapaxar one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Total Total of all reporting groups

Baseline Measures
    Placebo     Vorapaxar     Total  
Number of Participants  
[units: participants]
  13224     13225     26449  
Age, Customized  
[units: Participants]
     
<65 years     8273     8188     16461  
65-<75 years     3445     3523     6968  
>=75 years     1506     1514     3020  
Gender  
[units: Participants]
     
Female     3172     3154     6326  
Male     10052     10071     20123  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, or Urgent Coronary Revascularization (UCR) Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

2.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

3.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

4.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

5.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

6.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

7.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or Urgent Hospitalization for Vascular Cause of Ischemic Nature (UH-VCIN) Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

8.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

9.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

10.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

11.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

12.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

13.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

14.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

15.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

16.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

17.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

18.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

19.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Met GUSTO Moderate or Severe Bleeding Criteria Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

20.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

21.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

22.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

23.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or UH-VCIN Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

24.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

25.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

26.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

27.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

28.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

29.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

30.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

31.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization   [ Time Frame: up to 3 years ]

32.  Post-Hoc:   Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization   [ Time Frame: up to 3 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
Prior to the completion of the study, based on a communication from the Data and Safety Monitoring Board, all participants who had experienced a stroke either before or during the study had study drug discontinued.


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00526474     History of Changes
Other Study ID Numbers: P04737, TRA 2°P - TIMI 50, 2006-002942-12, MK-5348-015
Study First Received: September 6, 2007
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration