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

Phase 4

Completed

• Conditions: Cardiovascular Disease; Overweight
• Interventions: Drug: clopidogrel

• Registration Number: NCT01509365
• Lead Sponsor: Les Laboratoires des Médicaments Stériles

Brief Summary

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

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-13
• Status Verified: 2014-10
• Primary Completion: 2015-02
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-06
• Last Update Posted: 2015-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
double dose	clopidogrel	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.
simple dose	clopidogrel	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.

Primary Outcome Measures

Name	Time	Method
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation	6 months

Secondary Outcome Measures

Name	Time	Method
ADP-induced platelet aggregation assessed by VerifyNow test	7 days after selection of patients

Trial Locations

Locations (1)

cardiology department, hospital Fattouma Bourguiba; 🇹🇳 Monastir, Tunisia