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

Les Laboratoires des Médicaments Stériles116 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

116

Conditions

Cardiovascular Disease Overweight

Interventions

clopidogrelDRUG

2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.

clopidogrelDRUG

1 tablet of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

cardiology department, hospital Fattouma Bourguiba

Monastir, Monastir Governorate, Tunisia

Outcomes

Primary Outcomes

Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation

Time frame: 6 months

Secondary Outcomes

ADP-induced platelet aggregation assessed by VerifyNow test

Time frame: 7 days after selection of patients

Data from ClinicalTrials.gov

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