Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27 (PLATO-dose)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|