Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Particpants With Acute Coronary Syndrome (TRA•CER) (Study P04736)

This study has been terminated.
(The trial was terminated at the request of the Data and Safety Monitoring Board.)
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00527943
First received: September 7, 2007
Last updated: October 9, 2014
Last verified: October 2014
Results First Received: May 9, 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
Myocardial Ischemia
Myocardial Infarction
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 the planned study completion, the Data Safety Monitoring Board recommended that all participants stop treatment and that the study be closed-out. The protocol-defined target number of primary efficacy endpoints had been reached by this time. However, follow-up in the study was terminated earlier than planned.

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 Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Vorapaxar Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.

Participant Flow:   Overall Study
    Placebo     Vorapaxar  
STARTED     6471     6473  
Received Treatment     6441     6446  
COMPLETED     6311     6327  
NOT COMPLETED     160     146  



  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 Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Vorapaxar Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Total Total of all reporting groups

Baseline Measures
    Placebo     Vorapaxar     Total  
Number of Participants  
[units: participants]
  6471     6473     12944  
Age, Customized  
[units: Participants]
     
<65 years     3369     3390     6759  
65 to <75 years     2006     1973     3979  
>= 75 years     1096     1110     2206  
Gender  
[units: Participants]
     
Female     1822     1810     3632  
Male     4649     4663     9312  



  Outcome Measures
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1.  Primary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, Stroke, Recurrent Ischemia With Re-hospitalization, and/or Urgent Coronary Revascularization Within 2 Years From Randomization   [ Time Frame: Up to 2 years ]

2.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, and/or Stroke Within 2 Years From Randomization   [ Time Frame: up to 2 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 2 Years From Randomization   [ Time Frame: Up to 2 years ]

4.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 2 Years From Randomization   [ Time Frame: Up to 2 years ]

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

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

7.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, RIR, or UCR Within 2 Years From Randomization   [ Time Frame: Up to 2 years ]

8.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, or UCR Within 2 Years From Randomization   [ Time Frame: Up to 2 years ]

9.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 2 Years From Randomization   [ Time Frame: Up to 2 years ]

10.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 2 Years From Randomization   [ Time Frame: Up to 2 years ]

11.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced RIR Within 2 Years From Randomization   [ Time Frame: Up to 2 years ]

12.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 2 Years From Randomization   [ Time Frame: Up to 2 years ]

13.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 2 Years From Randomization   [ Time Frame: Up to 2 years ]

14.  Secondary:   Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 2 Years From Randomization   [ Time Frame: Up to 2 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 planned study completion, the Data Safety Monitoring Board recommended that all participants stop treatment and that the study be closed-out. The protocol-defined target number of primary efficacy endpoints had been reached by this time.


  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


Publications of Results:
Publications automatically indexed to this study:


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00527943     History of Changes
Other Study ID Numbers: P04736, TRA•CER, 2006-002809-31, MK-5348-014
Study First Received: September 7, 2007
Results First Received: May 9, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration