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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Overweight
• Intervention / Treatment: Drug: clopidogrel; Drug: clopidogrel

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • cardiology department, hospital Fattouma Bourguiba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: sensible; Patients who show adequate response to loading dose of clopidogrel and receive standard 1x75 mg clopidogrel for at least 7 days.
ACTIVE_COMPARATOR: 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.	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.
EXPERIMENTAL: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Les Laboratoires des Médicaments Stériles
• Collaborators: University Hospital Fattouma Bourguiba
• Investigators: Study Chair: Faouzi Maatouk, MD, Hospital Fattouma Bourguiba; Principal Investigator: Khaldoun Ben Hamda, MD, Hospital Fattouma Bourguiba; Principal Investigator: Sonia Hamdi, MD, Hospital Fattouma Bourguiba; Principal Investigator: Mohsen Hassine, Hospital Fattouma Bourguiba

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 12, 2012
• First Posted (ESTIMATE): January 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 7, 2015
• Last Update Submitted That Met QC Criteria: May 6, 2015
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: overweight; cardiovascular disease; clopidogrel; antiplatelet agents; maintenance dose
• Additional Relevant MeSH Terms: Body Weight; Cardiovascular Diseases; Overweight; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: 03 PID 11