Patent Versus Generic Clopidogrel in Acute Coronary Syndrome

Study Overview
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Brief Summary
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Ischemic heart disease is the leading cause of death and disability in developed countries and is responsible for a third of deaths in persons over 35 years . The most severe form of ischemic heart disease is sudden death and acute coronary syndrome (ACS). There is evidence that early and optimal treatment of ACS decreases mortality. Within the optimal treatment, these patients must receive a reperfusion therapy as mechanical or pharmacologic treatment. In addition to reperfusion treatment, antiplatelet therapy is a central part of the management. Aspirin plus a P2Y12 inhibitor have been shown to decrease mortality. In our country, clopidogrel is the more accessible and used P2Y12 inhibitor; however, it has been shown to have a wide variability in response and this variability could be influenced by different pharmacological, genetic and environmental factors. Platelet reactivity measured by aggregometry predicts major cardiovascular events in ACS patients treated with clopidogrel. Due to their frequent prescription, generic clopidogrel efficacy must be evaluated. The purpose of this study is to compare the platelet reactivity in patients with ACS receiving clopidogrel generic versus patent.

Official Title
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Comparison of Platelet Reactivity in Patients With Acute Coronary Syndrome Given Patent Clopidogrel Versus Generic Clopidogrel: Randomized Controlled Trial

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Generic clopidogrel
* Drug: Patent clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 and over Diagnosis of acute coronary syndrome Patients receiving 300 mg of Clopidogrel load and a single dose of 75 mg daily Signature of informed consent Exclusion Criteria: Active bleeding or absolute contraindication for antiplatelet use Chronic kidney disease with creatinine clearance <30 ml / min Liver damage documented as elevated aspartate aminotransferase/alanine aspartate 2 times upper normal limit (UNL) and/or total bilirubin > 2 times UNL Prescribed antiplatelet therapy, other than aspirin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Generic clopidogrel<br>Patients are assigned to take generic clopidogrel | Drug: Generic clopidogrel<br>* Comparison of different brands of clopidogrel: *Clopidogrel (generic) 300mg orally single dose on day 0. Later, clopidogrel 75mg orally single dose on days 1, 2 and 3.<br>|
| Active Comparator: Patent clopidogrel<br>Patients are assigned to take patent clopidogrel (Plavix) | Drug: Patent clopidogrel<br>* Comparison of different brands of clopidogrel: *Clopidogrel (Plavix) 300mg orally single dose on day 0. Later, clopidogrel 75mg orally single dose on days 1, 2 and 3.<br>* Other names: Plavix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reactivity change | Change in platelet reactivity measured from day 0 to day 3 of Clopidogrel therapy | Day 0 and Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Clopidogrel, Platelet reactivity