Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27 (PLATO-dose)
|ClinicalTrials.gov Identifier: NCT01509365|
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : May 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Overweight||Drug: clopidogrel||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||May 2015|
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.
- Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation [ Time Frame: 6 months ]
- ADP-induced platelet aggregation assessed by VerifyNow test [ Time Frame: 7 days after selection of patients ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509365
|cardiology department, hospital Fattouma Bourguiba|
|Monastir, Tunisia, 5000|
|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|