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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Disease; Overweight	Drug: clopidogrel	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	116 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	December 2011
Actual Primary Completion Date :	February 2015
Actual Study Completion Date :	May 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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; 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.

Outcome Measures

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Primary Outcome Measures :

1. Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. ADP-induced platelet aggregation assessed by VerifyNow test [ Time Frame: 7 days after selection of patients ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Les Laboratoires des Médicaments Stériles

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov Identifier:	NCT01509365 History of Changes
Other Study ID Numbers:	03 PID 11
First Posted:	January 13, 2012
Last Update Posted:	May 7, 2015
Last Verified:	October 2014

Keywords provided by Les Laboratoires des Médicaments Stériles:

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

Additional relevant MeSH terms:

Cardiovascular Diseases; Overweight; Body Weight; Signs and Symptoms; Clopidogrel; Ticlopidine; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists	Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Fibrinolytic Agents; Fibrin Modulating Agents; Cytochrome P-450 CYP2C19 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors