Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27

Study Overview
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Brief Summary
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The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel in the patient population overweight or obese with a body mass index (BMI) ≥ 27 kg.m-2.

Detailed Description
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The goal is to evaluate the effect of the double maintenance dose of clopidogrel versus single dose in patients with proven coronary and with BMI ≥ 27 kg.m-2 1 - Biologically: study and compare the respective effects of the double dose and single dose of clopidogrel on platelet aggregation. 2 - Clinically: to study and compare the cardiovascular events and adverse effects depending on the dose of clopidogrel.

Official Title
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Evaluation the Effect of the Double Maintenance Dose of Clopidogrel Versus Single Dose in Patients With Coronary Artery Disease With a BMI ≥ 27 kg.m-2

Conditions
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Cardiovascular Disease, Overweight

Intervention / Treatment
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* Drug: clopidogrel
* Drug: clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, Old (e) of more than 20 years BMI ≥ 27kg.m-2 Patients hospitalized for acute coronary syndrome (Whatever the ST segment and troponin dosage) Patients with proven coronary candidates for treatment with Clopidogrel (who received a loading dose of 600mg over 2 hours or treated with 75 mg/day or 150mg / day of clopidogrel for longer than 7 days) Exclusion Criteria: Patients unwilling. Patient participating in another study. Patients with cardiogenic shock Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability Patients scheduled for surgery in less than 6 months ischemic stroke older than 6 weeks. History of hemorrhagic stroke (any time) Patients on or candidates for AVK Patients with a different anti ADP (ticlopidine, prasugrel) Patients with an indication against clopidogrel (side effects, bleeding ...) Thrombocytopenia < 100000/mm3 anemia (Ht < 30%) Thrombocythaemia (Ht > 52%) Pregnancy

Ages Eligible for Study
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Minimum Age: 20 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: sensible<br>Patients who show adequate response to loading dose of clopidogrel and receive standard 1x75 mg clopidogrel for at least 7 days. | |
| Active Comparator: simple dose<br>Patients who show suboptimal response to loading dose of clopidogrel and receive 1x75 mg clopidogrel for 1 month followed by standard 75 mg clopidogrel for 3 months to one year. | Drug: clopidogrel<br>* 1 tablet of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.<br>|
| Experimental: double dose<br>Patients who show suboptimal response to loading dose of clopidogrel and receive 1x150 mg clopidogrel for 1 month followed by standard 75 mg clopidogrel for 3 months to one year. | Drug: clopidogrel<br>* 2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADP-induced platelet aggregation assessed by VerifyNow test |  | 7 days after selection of patients | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, maintenance dose, clopidogrel, overweight, antiplatelet agents