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)

Completed

Phase 3 Results

Trial Description

The study is designed to determine whether vorapaxar, when added to the existing standard of care (SOC) for preventing heart attack and stroke (eg, aspirin, clopidogrel) in participants with a known history of atherosclerosis, will yield additional benefit over the existing standard of care without vorapaxar 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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: matching tablet daily for at least 1 year
    ARM 1: Kind: Experimental
    Label: Placebo
  • SCH-530-348 Drug
    Intervention Desc: is a thrombin receptor (PAR-1) antagonist based on the natural product himbacine.
  • SCH 530348 Drug
    Intervention Desc: 2.5-mg tablet daily for at least 1 year
    ARM 1: Kind: Experimental
    Label: SCH 530348
  • Vorapaxar Drug
    Other Names: SCH 530348; MK-5348
    Intervention Desc: 2.5-mg tablet daily for at least 1 year
    ARM 1: Kind: Experimental
    Label: Vorapaxar
    Description: 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.

Trial Design

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

Patient Involvement

Patient will be randomized to one of two arms: 1) placebo matching tablet daily for at least 1 year or SCH-530-348 2.5-mg tablet daily for at least 1 year.

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, and urgent coronary revascularization
Secondary The key secondary efficacy endpoint is the first occurrence of any component of the composite of cardiovascular death, MI, and stroke.
Primary The primary efficacy endpoint of the study is the first occurrence of any component of the composite of cardiovascular death, MI, stroke, and urgent coronary revascularization. Through the end of the study. No
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 up to 3 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization up to 3 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 3 Years From Randomization up to 3 years Yes
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization up to 3 years Yes
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization up to 3 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization up to 3 years No
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 up to 3 years No
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 up to 3 years No
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 up to 3 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization up to 3 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization up to 3 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization up to 3 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization up to 3 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization up to 3 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization up to 3 years No
Secondary Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization up to 3 years No

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