Platelet Reactivity After Switching from Clopidogrel to Prasugrel in Patients with Coronary Artery Disease
Not Applicable
- Conditions
- Ischemic heart disease
- Registration Number
- JPRN-UMIN000014528
- Lead Sponsor
- Chiba University Hospital
- Brief Summary
The prevalence of HPR and the PRU level were significantly lower on prasugrel maintenance therapy compared with the clopidogrel therapy before and after switching.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 53
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. Weigh 50 kg or less 5. low platelet counts (less than 10*10^4) 6. Pregnant 7. Patients who are taking anticoagulants 8. Patients who are planned to administer thrombolytic agents 9. Patients scheduled for PCI or coronary artery bypass graft during this study 10. Patients who are taking ticlopidine or cilostazol 11. 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 high on-treatment platelet reactivity (HPR) before and 2 weeks after switching from clopidogrel 75 mg maintenance dose to prasugrel 3.75 mg maintenance dose. We measure the platelet inhibition as the PRU from the VerifyNow P2Y12 platform assay with the predefined thresholds of PRU > 208 for HPR and PRU < 95 for LPR, respectively.
- Secondary Outcome Measures
Name Time Method The secondary efficacy endpoints are the variation in the rate of high on-treatment platelet reactivity (HPR) before and 2 weeks after switching from clopidogrel 75 mg maintenance dose to prasugrel 3.75 mg maintenance dose and 2 weeks after switching again from prasugrel 3.75 mg to clopidogrel 75 mg, the difference of the mean PRU and mean inhibition rate between clopidogrel 75 mg and prasugrel 3.75 mg, the average value of the change of PRU, and the relation between CYP2C19 polymorphism and platelet inhibition. The safety endpoints are the rate of bleeding events according to TIMI bleeding criteria, ischemic events, stent thrombosis, myocardial infarction during this study.