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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-05-31

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.

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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.

Conditions

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Cardiovascular Disease Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sensible

Patients who show adequate response to loading dose of clopidogrel and receive standard 1x75 mg clopidogrel for at least 7 days.

Group Type NO_INTERVENTION

No interventions assigned to this group

simple dose

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.

Group Type ACTIVE_COMPARATOR

clopidogrel

Intervention Type DRUG

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

double dose

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.

Group Type EXPERIMENTAL

clopidogrel

Intervention Type DRUG

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

Interventions

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clopidogrel

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

Intervention Type DRUG

clopidogrel

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

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No