Clinical trial NCT01509365: Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disease
Overweight
Keywords: cardiovascular disease
maintenance dose
clopidogrel
overweight
antiplatelet agents
Lead sponsor: Les Laboratoires des Médicaments Stériles
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Fattouma Bourguiba
First posted: 2012-01-13
Enrollment: 116
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation
timeFrame: 6 months
Secondary outcomes:
measure: ADP-induced platelet aggregation assessed by VerifyNow test
timeFrame: 7 days after selection of patients
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: cardiology department, hospital Fattouma Bourguiba
Study officials:
affiliation: hospital Fattouma Bourguiba
name: Faouzi Maatouk, MD
role: STUDY_CHAIR
affiliation: Hospital Fattouma Bourguiba
name: Khaldoun Ben Hamda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Fattouma Bourguiba
name: Sonia Hamdi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Fattouma Bourguiba
name: Mohsen Hassine
role: PRINCIPAL_INVESTIGATOR
References: