Acute Coronary Syndrome Clinical Trial
Official title:
Comparison of Platelet Reactivity in Patients With Acute Coronary Syndrome Given Patent Clopidogrel Versus Generic Clopidogrel: Randomized Controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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