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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Cerebrovascular Accident; Ischemia; Myocardial Infarction; Peripheral Arterial Disease; Atherosclerosis

Treatments: Drug: Placebo; Drug: Vorapaxar

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00526474

TRA 2°P - TIMI 50

2006-002942-12

MK-5348-015 (Other Identifier)

P04737

Details and patient eligibility

About

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.

Enrollment: 26,449 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26,449 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

1 placebo tablet, orally, daily 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.

Treatment:

Drug: Placebo

Vorapaxar

Experimental group

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.

Treatment:

Drug: Vorapaxar