Safety and eficity of 2.5mg prasugrel therapy in the eldely or low body weight Japanese patients undergoing percutaneous coronary interventio
Phase 4
- Conditions
- Ischemic Heart Disease
- Registration Number
- JPRN-UMIN000019424
- Lead Sponsor
- Chiba University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients with contraindications to prasugrel 2. Patients who have severe liver problem 3. Patients who have severe kidney problem 4. History of stroke or transient ischemic attack 5. low platelet counts (less than 10*10^4) 6. Patients who are taking anticoagulants 7. Patients who are planned to administer thrombolytic agents 8. Patients scheduled for PCI or CABG during this study 9. Patients who are taking ticlopidine or cilostazol or prasugrel. 10. Patients judged as inappropriate for trial entry
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint is the variation in the rate of low on-treatment platelet reactivity (LPR) among Prasugrel 3.75 mg and prasugrel 2.5 mg maintenance dose. We measure the platelet inhibition as the PRU from the VerifyNow P2Y12 platform assay with the predefined thresholds of PRU < 95 for LPR
- Secondary Outcome Measures
Name Time Method The secondary efficacy endpoints are the variation in the rate of high on-treatment platelet reactivity (HPR) and optimal on treatment platlet reactivity (OPR) amomg clopidogrel 75 mg maintenance dose , prasugrel 3.75 mg maintenance dose and prasugrel 2.5mg maintenance dose, the difference of the mean PRU and mean inhibition rate, the average value of the change of PRU, the relation between coronary stent and platlet inhibition, the relation between date from InBody S20 and platelet inhibition and the relation between CYP2C19 polymorphism and platelet inhibition. The safety endpoints are the rate of bleeding events according to BARC criteria, ischemic events, stent thrombosis, myocardial infarction during this study.