Prasugrel Re-load Strategies

Study Overview
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Brief Summary
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A higher degree of platelet inhibition remains the goal of peri-interventional and long-term anti-thrombotic therapy in patients with coronary artery disease. In clinical practice, patients undergoing percutaneous coronary intervention with stent implantation who are already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior observations showing that higher inhibition of platelet aggregation may be achieved by giving a loading dose of clopidogrel in patients with coronary artery disease while on chronic clopidogrel therapy. However, to date it is unknown if greater inhibition of platelet aggregation can be achieved by adding a prasugrel loading dose in patients on chronic prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a prasugrel re-load strategy in patients on already on chronic prasugrel therapy will be useful.

Official Title
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Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Prasugrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with angiographically documented coronary artery disease. Age between 18 to 74 years On treatment with prasugrel 10mg/daily for at least 14 days. Exclusion Criteria: Blood dyscrasias or bleeding diathesis Antiplatelet treatment with clopidogrel or ticlopidine Recent antiplatelet treatment (< 14 days) with a glycoprotein IIb/IIIa antagonist Platelet count <100x106/µL Active bleeding or hemodynamic instability. Unstable angina, acute or recent (<14 days) myocardial infarction. Serum creatinine >2 mg/dL Baseline ALT >2.5 times the upper limit of normal Oral anticoagulation with a coumarin derivative History of stroke, TIA or intracranial bleeding Weight <60kg Pregnant females

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prasugrel 60mg<br>Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel | Drug: Prasugrel<br>* Prasugrel 10mg, 30mg, or 60mg<br>|
| Active Comparator: Prasugrel 30mg<br>Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel | Drug: Prasugrel<br>* Prasugrel 10mg, 30mg, or 60mg<br>|
| No Intervention: Prasugrel 10mg<br>Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRI Levels at 4 Hours |  | 4 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, percutaneous coronary revascularization, prasugrel therapy