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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Les Laboratoires des Médicaments Stériles.
Recruitment status was  Recruiting
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

January 9, 2012
January 12, 2012
December 2011
September 2012   (final data collection date for primary outcome measure)
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01509365 on ClinicalTrials.gov Archive Site
ADP-induced platelet aggregation assessed by VerifyNow test [ Time Frame: 7 days after selection of patients ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cardiovascular Disease
  • Overweight
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Sonia Hamdi, MD 216 98684148 sony.hamdy@laposte.fr
Tunisia
 
NCT01509365
03 PID 11
Yes
Les Laboratoires des Médicaments Stériles
Les Laboratoires des Médicaments Stériles
University Hospital Fattouma Bourguiba
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
Les Laboratoires des Médicaments Stériles
January 2012

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