Clinical trial NCT00684515: Trial to Assess the Safety of Vorapaxar in Japanese Subjects With Cerebral Infarction (P05005; MK-5348-017)
Official title: Phase II Study of SCH 530348 in Subjects With Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Infarction
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE)
timeFrame: Up to Day 121
Secondary outcomes:
measure: Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events
timeFrame: Up to Day 60
measure: Number of Participants With MACE or Death
timeFrame: Up to Day 121
measure: Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit
timeFrame: Up to Day 60
measure: Mean CD40 Ligand Levels By Study Visit
timeFrame: Up to Day 60
measure: Mean Membrane-Bound P-Selectin Levels By Study Visit
timeFrame: Up to Day 60
Other outcomes:
Locations:
Study officials:
References:
citation: Shinohara Y, Goto S, Doi M, Jensen P. Safety of the novel protease-activated receptor-1 antagonist vorapaxar in Japanese patients with a history of ischemic stroke. J Stroke Cerebrovasc Dis. 2012 May;21(4):318-24. doi: 10.1016/j.jstrokecerebrovasdis.2010.09.005. Epub 2010 Oct 14.