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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)

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ClinicalTrials.gov Identifier: NCT00527943
Recruitment Status : Terminated (The trial was terminated at the request of the Data and Safety Monitoring Board.)
First Posted : September 11, 2007
Results First Posted : June 9, 2014
Last Update Posted : May 5, 2017
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Atherosclerosis
Myocardial Ischemia
Myocardial Infarction
Interventions: Drug: Vorapaxar
Drug: Placebo

  Participant Flow

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

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 
Overall Participants Analyzed 
[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 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      1822  28.2%      1810  28.0%      3632  28.1% 
Male      4649  71.8%      4663  72.0%      9312  71.9% 


  Outcome Measures

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 9

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 ]
  Show Outcome Measure 10

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

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

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 ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 14


  Serious Adverse Events


  Other Adverse Events


  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
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

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 by ClinicalTrials.gov Identifier (NCT Number):


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 ( Other Identifier: Merck Study Number )
First Submitted: September 7, 2007
First Posted: September 11, 2007
Results First Submitted: May 9, 2014
Results First Posted: June 9, 2014
Last Update Posted: May 5, 2017