Phase 2
Completed N=90
Trial to Assess the Safety of Vorapaxar in Japanese Subjects With Cerebral Infarction (P05005; MK-5348-017)
Source: ClinicalTrials.gov NCT00684515 ↗Enrolled (actual)
90
Serious AEs
6.7%
Results posted
Jul 2014
Primary outcomePrimary: Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE) — 27; 27; 22 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE) |
27; 27; 22 | — |
| SECONDARY Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With MACE or Death |
1; 1; 3; 0; 0; 0 | — |
| SECONDARY Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit |
0.65; 0.67; 0.56; 0.77; 0.49; 0.41 | — |
| SECONDARY Mean CD40 Ligand Levels By Study Visit |
6.5; 8.3; 5.9; 7.2; 5.8; 5.6 | — |
| SECONDARY Mean Membrane-Bound P-Selectin Levels By Study Visit |
15.7; 19.5; 17.4; 19.9; 16.6; 17.1 | — |
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 200 mmHg or diastolic blood pressure >110 mmHg).
- Major surgery within 2 weeks before obtaining consent.
- Known platelet count 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.
Data sourced from ClinicalTrials.gov (NCT00684515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.