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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01509365
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : May 7, 2015
Sponsor:
Collaborator:
University Hospital Fattouma Bourguiba
Information provided by (Responsible Party):
Les Laboratoires des Médicaments Stériles

Tracking Information
First Submitted Date  ICMJE January 9, 2012
First Posted Date  ICMJE January 13, 2012
Last Update Posted Date May 7, 2015
Study Start Date  ICMJE December 2011
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation [ Time Frame: 6 months ]
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
 (submitted: January 12, 2012)
ADP-induced platelet aggregation assessed by VerifyNow test [ Time Frame: 7 days after selection of patients ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Arms  ICMJE
  • 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 Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2015)
116
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2012)
150
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date February 2015   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01509365
Other Study ID Numbers  ICMJE 03 PID 11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account Les Laboratoires des Médicaments Stériles
Verification Date October 2014

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