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Completed

NCT Number: NCT01509365

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

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.

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Key information

Conditions

Cardiovascular Disease Body Weight Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

cardiology department, hospital Fattouma Bourguiba

Monastir, Monastir Governorate, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.

Primary outcomes

  1. Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation

    Time frame: 6 months

Secondary outcomes

  1. ADP-induced platelet aggregation assessed by VerifyNow test

    Time frame: 7 days after selection of patients

Sponsors and collaborators

Lead sponsor

Les Laboratoires des Médicaments Stériles

Industry

Collaborators

  • University Hospital Fattouma Bourguiba

Registry information

Official study 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

Acronym: PLATO-dose

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2012
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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