Trial to Assess the Safety of Vorapaxar in Japanese Subjects With Cerebral Infarction (P05005; MK-5348-017)
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Intervention: Vorapaxar 2.5 mg; Vorapaxar 1 mg; Placebo; Aspirin 75-150 mg
Intervention description: Oral tablets; once daily for 60 days.; Oral tablets; once daily for 60 days; oral tablets; once daily for 60 days; oral tablets; once daily for 60 days
Intervention MeSH terms: Aspirin; 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: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study is designed to assess safety of Vorapaxar when added to standard of care (aspirin)
      in Japanese subjects with cerebral infarction. The study will assess incidence and
      tolerability of bleeding, major adverse cardiac events, all adverse events, and effect on
      expression of markers of inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women at least 18 years old with last cerebral infarction (excluding
             cardiogenic cerebral embolism) having occurred from 14 days to less than 1 year after
             onset (at the time of obtaining consent), with stable nervous system for more than 24
             hours and known course of disease.

          -  Participants confirmed to have cerebral infarction lesion by brain computerized
             tomography (CT) or magnetic resonance imaging (MRI).

          -  Both of in-participant and out-participant

          -  Willing to give appropriate informed consent and complete all study-related procedures
             and able to adhere to dosing and visit schedules.

          -  Women of child-bearing potential (all postmenopausal women who are <1 year 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 study drug, and for 60 days after
             completion or discontinuation of the medication.

        Exclusion Criteria:

          -  Pregnancy and nursing patients (premenopausal women should have a negative pregnancy
             test result confirmed before enrollment)

          -  Participant with any serious complication or any condition that the investigator feels
             that would cause a significant hazard to the participant if the study drug is
             administered.

          -  Known hypersensitivity to any component of the study drug.

          -  Participation in a study or use of an investigational study drug within 30 days before
             obtaining consent.

          -  Member of the staff personnel directly involved with this study

          -  Family member of the study staff.

          -  History of a bleeding diathesis, or evidence of active abnormal bleeding within 30
             days before obtaining consent.

          -  History of cerebral hemorrhage.

          -  Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure
             >110 mmHg).

          -  Major surgery within 2 weeks before obtaining consent.

          -  Known platelet count <100,000/mm^3

          -  Participants confirmed to have cerebral bleeding or any causes of cerebral bleeding by
             brain CT or MRI.

          -  Participants with transient ischemic attack (TIA), progressive stroke or cardiogenic
             cerebral embolism.

          -  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 system or hepatic disease, or aspartate
             aminotransferase (GOT) or alanine aminotransferate (GPT) activity more than two times
             greater than the upper limit of the laboratory normal range.

          -  Participants with contraindictation to aspirin.

          -  Scheduled to have PCI (peripheral coronary intervention), peripheral interventional
             event, carotid endarterectomy, intra- and extra- cranial bypass surgery and
             intravascular surgery (angioplasty) during the study period.

          -  Combination therapy with unfractionated heparin, tissue plasminogen activator,
             urokinase, warfarin, factor Xa inhibitor, direct thrombin inhibitor or antiplatelet
             agents other than aspirin after obtaining consent, or scheduled to have the above
             combination therapy.

          -  Any serious impairment which would make detection of new ischemic events difficult
             (eg, bedridden participants, participants with total nursing care, dementia
             participants, etc.) or consciousness disturbance which may cause aspiration of the
             study drug.