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)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26,449 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerosis
• Ischemia
• Myocardial Infarction
• Cerebrovascular Accident
• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Vorapaxar	2.5-mg tablet daily for at least 1 year
DRUG	Placebo	matching tablet daily for at least 1 year

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2007-09-10
• Last updated: 2018-09-21
• Results posted: 2014-06-18