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

Overweight Clinical Trial

— PLATO-dose  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509365
• Other study ID #: 03 PID 11
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2012
• Last updated: May 6, 2015
• Start date: December 2011
• Est. completion date: May 2015

Study information

• Verified date: October 2014
• Source: Les Laboratoires des Médicaments Stériles
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Office of Pharmacies and Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Overweight

Intervention

Drug:
• clopidogrel
2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.
• clopidogrel
1 tablet of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.

Locations

Country	Name	City	State
Tunisia	cardiology department, hospital Fattouma Bourguiba	Monastir

Sponsors (2)

Lead Sponsor	Collaborator
Les Laboratoires des Médicaments Stériles	University Hospital Fattouma Bourguiba

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation		6 months	No
Secondary	ADP-induced platelet aggregation assessed by VerifyNow test		7 days after selection of patients	No