Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016)
Condition: Atherosclerosis; Myocardial Ischemia; Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Atherosclerosis; Myocardial Ischemia; Infarction; Ischemia
Intervention: Vorapaxar; Placebo; Aspirin; Clopidogrel
Intervention description: Oral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days; Oral tablets; matching placebo for SCH 530348 loading and maintenance doses for 59 days; Loading dose of 75-325 mg on Day 1, then 75-100 mg once daily for 60 days.; 100 mg two or three times daily for 60 days.
Intervention MeSH terms: Aspirin; Clopidogrel; Vorapaxar
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study is designed to assess safety and effects of vorapaxar, when added to standard of
      care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study
      may also provide information about the effect of vorapaxar on preventing heart attack and
      stroke in this subject population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged 18 years or more with history of cardiac ischemia related chest
             discomfort of > 10 minutes duration < 24 hours prior to randomization, and having at
             least 1 of the following A or B. Participants who are planned to undergo PCI will be
             the target participants.

               -  A: Positive biomarkers [Elevated troponin I or creatinine kinase MB isozyme
                  greater than the site's upper limit of normal (ULN)] at or before registration

               -  B: Electrocardiogram (ECG) changes: ST segment depression >= 0.1 mV (>=1 mm), or
                  transient (<30 minutes) ST segment elevation >= 0.1 mV (>=1 mm) in at least 2
                  contiguous leads

          -  Willing to give appropriate informed consent and complete all study-related
             procedures, and able to adhere to dosing and all visit schedules.

          -  Women of child-bearing potential (all postmenarchal women who are <1 years menopausal
             or who have not had surgical sterilization or a hysterectomy are considered to be
             women of child-bearing potential) must agree to use a medically accepted method of
             contraception while receiving protocol-specified medication, and for 60 days after
             stopping the medication.

        Exclusion Criteria:

          -  Pregnant and nursing mothers (premenopausal women should have a negative pregnancy
             test result confirmed before enrollment)

          -  Any serious illness or any condition that the investigator feels would pose a
             significant hazard to the participant if investigational therapy were initiated

          -  known hypersensitivity to any component of the current investigational product;

          -  Participation in a study of experimental therapy or use of any investigational drug
             within 30 days before enrollment

          -  Member of the staff personnel directly involved with this study;

          -  Family member of the investigational study staff;

          -  History of a bleeding diathesis, or evidence of active abnormal bleeding within 30
             days before enrollment

          -  History of a hemorrhagic stroke at any time

          -  Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure
             >110 mm Hg) while receiving therapy;

          -  Major surgery within 2 weeks prior to enrollment

          -  Known platelet count <100,000/mm^3

          -  Uncontrolled cardiac arrhythmia;

          -  Known impairment of renal function (serum creatinine >2.0 mg/dL [>176.8 umol/L]),
             dysproteinemia, nephrotic syndrome, or other renal disease;

          -  Active or chronic hepatobiliary or hepatic disease, or aspartate aminotransferase
             (AST) or alanine aminotransferase (ALT) activity more than two times greater than the
             upper limit of the laboratory reference range

          -  Anticipated staged PCI

          -  Concurrent or anticipated treatment with warfarin, factor Xa inhibitor, direct
             thrombin inhibitor, or antiplatelet agents except aspirin and ticlopidine after
             enrollment

          -  Anticipated intracoronary brachytherapy