Phase 2
Completed N=117
Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016)
Source: ClinicalTrials.gov NCT00684203 ↗Enrolled (actual)
117
Serious AEs
15.0%
Results posted
Aug 2014
Primary outcomePrimary: Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI) — 40; 30; 21 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI) |
40; 30; 21 | — |
| SECONDARY Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI |
21; 19; 16; 14; 21 | — |
| SECONDARY Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI |
2; 0; 0; 5; 3; 2 | — |
| SECONDARY Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit |
5; 4; 3; 5; 4; 3 | — |
| SECONDARY Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit |
1.30; 2.00; 1.78; 1.28; 1.01; 2.99 | — |
| SECONDARY Mean CD40 Ligand Levels Among Participants Who Underwent PCI |
5.6; 6.9; 4.8; 5.9; 5.9; 6.2 | — |
| SECONDARY Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI |
24.8; 16.5; 15.9; 20.6; 16.4; 18.8 | — |
| SECONDARY Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge |
3; 0; 2; 0; 0; 1 | — |
| SECONDARY Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI |
1; 2; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI |
6; 15; 1 | — |
| SECONDARY Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events |
— | — |
| SECONDARY Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion |
1; 2; 0 | — |
| SECONDARY Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization |
0; 1; 0 | — |
| SECONDARY Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI |
2.57; 1.05; 6.94; 3.56; 2.65; 3.96 | — |
| SECONDARY Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI |
8.4; 4.6; 11.1; 10.1; 7.1; 12.9 | — |
| SECONDARY Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events |
0; 1; 0; 1; 2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women aged 18 years or more with history of cardiac ischemia related chest discomfort of > 10 minutes duration = 0.1 mV (>=1 mm), or transient ( = 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 200 mm Hg or diastolic blood pressure >110 mm Hg) while receiving therapy;
- Major surgery within 2 weeks prior to enrollment
- Known platelet count 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
Data sourced from ClinicalTrials.gov (NCT00684203). 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.