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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
  Purpose

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 Intervention Phase
Cardiovascular Disease
Overweight
 Drug: clopidogrel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Les Laboratoires des Médicaments Stériles:

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

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

Estimated Enrollment: 150
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509365

Contacts
Contact: Sonia Hamdi, MD 216 98684148 sony.hamdy@laposte.fr

Locations
Tunisia
cardiology department, hospital Fattouma Bourguiba Recruiting
Monastir, Tunisia, 5000
Contact: Sonia Hamdi, MD     216 98684148     sony.hamdy@laposte.fr    
Contact: Bouchoucha Mohamed, MD     216 98709397     m.bouchoucha@medis.com.tn    
Principal Investigator: Faouzi Maatoug, MD            
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

No publications provided

Responsible Party: Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov Identifier: NCT01509365     History of Changes
Other Study ID Numbers: 03 PID 11
Study First Received: January 9, 2012
Last Updated: January 12, 2012
Health Authority: Tunisia: Office of Pharmacies and Medicines

Keywords provided by Les Laboratoires des Médicaments Stériles:
cardiovascular disease
maintenance dose
clopidogrel
overweight
antiplatelet agents

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Overweight
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Body Weight
Signs and Symptoms
Clopidogrel
Platelet Aggregation Inhibitors
Ticlopidine
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013