Clinical trial NCT00526474: 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)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P - TIMI 50)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atherosclerosis
Ischemia
Myocardial Infarction
Cerebrovascular Accident
Peripheral Arterial Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: The TIMI Study Group
First posted: 2007-09-10
Enrollment: 26449
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Men and women at least 18 years old with evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems by one or more of the following:

* history of myocardial infarction (heart attack)
* history of ischemic stroke (stroke due to a blocked artery)
* history of peripheral arterial disease

Exclusion Criteria:

* history of intracranial hemorrhage or of central nervous system (CNS) surgery, tumor, or aneurysm
* any bleeding disorder or abnormality
* sustained severe hypertension or valvular heart disease
* current or recent platelet count \<100,000 mm\^3
* planned or ongoing treatment with a blood thinning medication
* pregnancy
* any significant medical or physiological condition or abnormality that could put the subject at increased risk or limit the subject's ability to participate for the duration of the study

Primary outcomes:
measure: 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
timeFrame: up to 3 years
Secondary outcomes:
measure: Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization
timeFrame: up to 3 years
measure: 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
timeFrame: up to 3 years
measure: Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization
timeFrame: up to 3 years
measure: Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization
timeFrame: up to 3 years
measure: Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization
timeFrame: up to 3 years
measure: 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
timeFrame: up to 3 years
measure: 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
timeFrame: up to 3 years
measure: Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization
timeFrame: up to 3 years
measure: Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization
timeFrame: up to 3 years
measure: Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization
timeFrame: up to 3 years
measure: Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization
timeFrame: up to 3 years
measure: Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization
timeFrame: up to 3 years
measure: Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization
timeFrame: up to 3 years
measure: Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization
timeFrame: up to 3 years
measure: Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization
timeFrame: up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
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