Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment

Study Overview
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Brief Summary
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Clopidogrel administration is considered standard of care in patients with stable coronary artery disease post PCI. However , a significant proportion of patients is considered clopidogrel resistant and this is shown to be accompanied by future adverse events. The hypothesis of the study is to define among consecutive outpatient clinics individuals with stable coronary artery disease being on chronic clopidogrel treatment, those that are clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment crossover will be performed without a washout period. At Day 28 platelet reactivity will be assessed as well.

Official Title
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Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment

Conditions
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Coronary Artery Disease (CAD)

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 with history of coronary artery disease under chronic (≥ 6 months) clopidogrel treatment High on-clopidogrel platelet reactivity (≥235 Platelet Reactivity Units as assessed with the VerifyNow assay) Written Informed Consent Exclusion Criteria: History of bleeding diathesis History of active bleeding within 6 months before randomization Chronic oral anticoagulation treatment Contraindications to antiplatelet treatment Known platelet function disorders Acute coronary syndrome within 30 days before randomization Cardiogenic shock Planned Percutaneous Coronary Intervention in the next 30 days Cancer Haemodialysis Platelet count < 100000/μL Hematocrit < 30% High likelihood of being unavailable on the Day 28 visit History of stroke Known allergy to clopidogrel and/or prasugrel

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 10mg per day | Drug: Prasugrel<br>* Prasugrel 10mg per day<br>|
| Active Comparator: Clopidogrel<br> | Drug: Clopidogrel<br>* Clopidogrel 150mg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Platelet Reactivity | Platelet reactivity in Platelet Reactivity Units (PRU) as assessed with the VerifyNow point of care assay will be measured at the end of the two treatment periods, namely at 14 and 28 days after randomization | At 14 and 28 days after randomization | 

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