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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01509365

Acronym

PLATO-dose

Enrollment

116

Registered

2012-01-13

Start date

2011-12-31

Completion date

2015-05-31

Last updated

2015-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Overweight

Keywords

cardiovascular disease, maintenance dose, clopidogrel, overweight, antiplatelet agents

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.

Interventions

DRUGclopidogrel

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026