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)
Condition: Atherosclerosis; Myocardial Ischemia; Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Atherosclerosis; Myocardial Ischemia; Infarction; Ischemia
Intervention: Vorapaxar; Placebo
Intervention description: oral tablets; 40-mg loading dose on first day, followed by 2.5 mg once daily for at least 1 year; oral tablets; matching placebo for vorapaxar; loading and maintenance dosing; once daily for at least 1 year
Intervention MeSH terms: Vorapaxar
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12944.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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