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

This study is currently recruiting participants.

Verified January 2012 by Les Laboratoires des Médicaments Stériles

Sponsor:

Collaborator:

University Hospital Fattouma Bourguiba

Information provided by (Responsible Party):

Les Laboratoires des Médicaments Stériles

ClinicalTrials.gov Identifier:

NCT01509365

First received: January 9, 2012

Last updated: January 12, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 9, 2012

Last Updated Date

January 12, 2012

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01509365 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

ADP-induced platelet aggregation assessed by VerifyNow test [ Time Frame: 7 days after selection of patients ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cardiovascular Disease
Overweight

Intervention ^ICMJE

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.

Study Arm (s)

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.

Intervention: Drug: clopidogrel
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.

Intervention: Drug: clopidogrel

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

December 2013

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sonia Hamdi, MD

216 98684148

sony.hamdy@laposte.fr

Location Countries ^ICMJE

Tunisia

Administrative Information

NCT Number ^ICMJE

NCT01509365

Other Study ID Numbers ^ICMJE

03 PID 11

Has Data Monitoring Committee

Yes

Responsible Party

Les Laboratoires des Médicaments Stériles

Study Sponsor ^ICMJE

Les Laboratoires des Médicaments Stériles

Collaborators ^ICMJE

University Hospital Fattouma Bourguiba

Investigators ^ICMJE

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

Information Provided By

Les Laboratoires des Médicaments Stériles

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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