Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Particpants With Acute Coronary Syndrome (TRA•CER) (Study P04736)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3

Conditions: Myocardial Ischemia; Myocardial Infarction; Atherosclerosis

Treatments: Drug: Vorapaxar; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00527943

MK-5348-014 (Other Identifier)

2006-002809-31

P04736

TRA•CER

Details and patient eligibility

About

The study is designed to determine whether vorapaxar, when added to the existing standard of care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute coronary syndrome, will yield additional benefit over the existing standard of care 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: 12,944 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Men and women at least 18 years old with current clinical manifestation of non-ST-segment-elevation myocardial infarction (heart attack) according to the following three criteria:

• current symptoms of cardiac ischemia (chest pain leading to cardiac ischemia or heart attack)

AND

• either of the following:

  • concurrent elevation of troponin I or T, or of creatine kinase - myocardial band (CK-MB) to a level above the upper limit of normal, OR
  • concurrent appropriate electrocardiographic evidence

AND

• any one (or more) of the following:

  • age >= 55 years
  • documented history of prior heart attack or coronary revascularization (eg, angioplasty [PCI], coronary artery replacement [CABG])
  • diabetes (documented use of insulin or oral hypoglycemic[s])
  • documented 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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12,944 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.

Treatment:

Drug: Placebo

Vorapaxar

Experimental group

Description:

Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.

Treatment:

Drug: Vorapaxar