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)

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: The Thrombolysis in Myocardial Infarction Study (TIMI) Group
• Treatments: Vorapaxar

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