Status:
COMPLETED
Prasugrel Versus Clopidogrel to TREAT High Platelet Reactivity
Lead Sponsor:
University of Pecs
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-74 years
Phase:
PHASE4
Brief Summary
MAIN AIM: To compare the pharmacological potency of administering adjusted 600 mg clopidogrel loading doses and 60 mg prasugrel in patients with high on-clopidogrel platelet reactivity (HPR) after PCI...
Detailed Description
Study rationale: After coronary stent implantation, aspirin plus thienopyridine therapy has been proven to be superior to aspirin alone or aspirin plus warfarin in reducing adverse thrombotic events....
Eligibility Criteria
Inclusion
- Age between 18-74 years
- PCI with stent implantation due to stable angina or acute coronary syndrome
- Platelet function assessment available 6-24 hours after PCI
- Multiplate-derived ADP-reactivity \> 47 U
Exclusion
- Age ≥75 years
- Prior TIA or stroke
- Body weight less than 60 kg
- Contraindication for aspirin / thienopyridines
- Severe liver failure (Child Pugh C)
- Need for oral anticoagulation in the following one month
- Planned discontinuation of antiplatelet treatment in one month
- Current bleeding disorder, active bleeding event (Weber positivity)
- Haemoglobin level at presentation \< 90 g/l
- Refused informed consent
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT01493999
Start Date
September 1 2011
End Date
April 1 2013
Last Update
October 8 2014
Active Locations (1)
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1
University of Pécs, Heart Institute
Pécs, Hungary, 7624