Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27 (PLATO-dose)
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.
|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|
- Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- ADP-induced platelet aggregation assessed by VerifyNow test [ Time Frame: 7 days after selection of patients ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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.
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.
2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509365
|Contact: Sonia Hamdi, MD||216 email@example.com|
|cardiology department, hospital Fattouma Bourguiba||Recruiting|
|Monastir, Tunisia, 5000|
|Contact: Sonia Hamdi, MD 216 98684148 firstname.lastname@example.org|
|Contact: Bouchoucha Mohamed, MD 216 98709397 email@example.com|
|Principal Investigator: Faouzi Maatoug, MD|
|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|