Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)
Overview
- Phase
- Phase 4
- Intervention
- Clopidogrel
- Conditions
- Platelet Reactivity
- Sponsor
- University of Patras
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Platelet reactivity
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. The aim of the study is to define in consecutive patients with acute coronary syndrome (ACS) undergoing PCI, those aged>75years and/or weighted<60 Kg with high on-clopidogrel platelet reactivity (Platelet Reactivity Units-PRU≥235) as estimated 24 hours post PCI with the VerifyNow assay. Those patients will be randomized after informed concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 15 and then treatment crossover will be performed. At day 30 platelet reactivity will be determined as well.
Investigators
Dimitrios Alexopoulos
Professor
University of Patras
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years old
- •Patients having PCI with stenting 24 hours prior randomization, meeting the following criteria :
- •Acute coronary syndrome (unstable angina or myocardial infarction)
- •TIMI risk score\>2
- •Platelet reactivity in PRU ≥235 24 hours post-PCI
- •Age≥75 years and/or weight\<60 Kg
- •Informed consent obtained in writing
Exclusion Criteria
- •A history of bleeding diathesis
- •Chronic oral anticoagulation treatment
- •Contraindications to antiplatelet therapy
- •Known platelet function disorders
- •PCI or coronary artery bypass surgery \< 3 months
- •Unsuccessful PCI (residual stenosis \> 30% or flow \< Thrombolysis in myocardial infarction flow 3)
- •Planned staged PCI in the next 30 days
- •Hemodynamic instability
- •hemodialysis
- •Creatinine clearance \<25 ml/min
Arms & Interventions
Clopidogrel
Clopidogrel 150mg per day for 15 days
Intervention: Clopidogrel
Prasugrel
Prasugrel 5mg for 15 days
Intervention: Prasugrel
Outcomes
Primary Outcomes
Platelet reactivity
Time Frame: 15 days
Platelet reactivity assessed with the VerifyNow assay at the end of each treatment period
Secondary Outcomes
- Hyporesponsiveness rate (PRU≥235) at the end of the 2 treatment periods(15 days)