Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).

Study Overview
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Brief Summary
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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. Additionally, clopidogrel resistance has been linked with the CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as estimated predischarge with the VerifyNow point of care system of platelet reactivity. Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment crossover will be performed. At day 60 platelet reactivity will be determined as well. In addition, in all patients genetic determination of CYP polymorphisms (including the CYP2C19)known to affect clopidogrel metabolism will be performed.

Official Title
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Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.

Conditions
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Coronary Artery Disease (CAD), Acute Coronary Syndrome (ACS)

Intervention / Treatment
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* Drug: prasugrel
* Drug: clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old Patients having PCI with stenting 24-48 hours prior randomization, for 1. Stable angina 2.Ischaemia in provocative test 3.Acute coronary syndrome (unstable angina or myocardial infarction) Written Informed consent Platelet reactivity units (PRU) (VerifyNow) >230 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 60 days Hemodynamic instability Cancer or hemodialysis Platelet count <100 000/ μL, hematocrit <30% Creatinine clearance <25 ml/min A life expectancy<1 year, inability to give informed consent High likelihood of being unavailable for the Day 60 follow up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prasugrel<br>prasugrel per os 10mg/day | Drug: prasugrel<br>* prasugrel 10 mg/day<br>|
| Active Comparator: clopidogrel<br>clopidogrel per os 150mg/day | Drug: clopidogrel<br>* clopidogrel per os 150mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics) |  | Day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary angioplasty, clopidogrel resistance, prasugrel