Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27 (PLATO-dose)

Les Laboratoires des Médicaments Stériles

Status and phase: Completed; Phase 4

Conditions: Overweight; Cardiovascular Disease

Treatments: Drug: clopidogrel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01509365

03 PID 11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 3 patient groups

sensible

No Intervention group

Description:

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

simple dose

Active Comparator group

Description:

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.

Treatment:

Drug: clopidogrel

Drug: clopidogrel

double dose

Experimental group

Description:

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.

Treatment:

Drug: clopidogrel

Drug: clopidogrel