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

Terminated

Phase 3 Results

Trial Description

The study is designed to determine whether vorapaxar, when added to the existing standard of care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute coronary syndrome, will yield additional benefit over the existing standard of care in preventing heart attack and stroke.
The study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.

Trial Stopped: The trial was terminated at the request of the Data and Safety Monitoring Board.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: oral tablets; matching placebo for vorapaxar; loading and maintenance dosing; once daily for at least 1 year
    ARM 1: Kind: Experimental
    Label: Placebo
  • SCH 530348 Drug
    Intervention Desc: oral tablets; 40-mg loading dose on first day, followed by 2.5 mg once daily for at least 1 year
    ARM 1: Kind: Experimental
    Label: SCH 530348
  • Vorapaxar Drug
    Other Names: SCH 530348; MK-5348
    Intervention Desc: oral tablets; 40-mg loading dose on first day, followed by 2.5 mg once daily for at least 1 year
    ARM 1: Kind: Experimental
    Label: Vorapaxar
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary efficacy endpoint of the study is the first occurrence of any component of the composite of cardiovascular death, MI, stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization. Through the end of the study. No
Secondary The key secondary efficacy endpoint is the first occurrence of any component of the composite of cardiovascular death, MI, and stroke. Through the end of the study. No
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 Up to 2 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, and/or Stroke Within 2 Years From Randomization up to 2 years No
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 Up to 2 years Yes
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 2 Years From Randomization Up to 2 years Yes
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 2 Years From Randomization Up to 2 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or MI Within 2 Years From Randomization Up to 2 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, RIR, or UCR Within 2 Years From Randomization Up to 2 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, or UCR Within 2 Years From Randomization Up to 2 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 2 Years From Randomization Up to 2 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 2 Years From Randomization Up to 2 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced RIR Within 2 Years From Randomization Up to 2 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 2 Years From Randomization Up to 2 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 2 Years From Randomization Up to 2 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 2 Years From Randomization Up to 2 years No

Sponsors