NCT01509365

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Les Laboratoires des Médicaments Stériles · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Disease
• Overweight

Interventions

Type	Name	Description
DRUG	clopidogrel	2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.
DRUG	clopidogrel	1 tablet of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-02-01
• Completion: 2015-05-01
• First posted: 2012-01-13
• Last updated: 2015-05-07

Locations

1 site across 1 country: Tunisia