Acute Coronary Syndrome
Conditions
Keywords
Acute Coronary Syndrome, Clopidogrel, Platelet reactivity
Brief summary
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.
Interventions
DRUGGeneric clopidogrel
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.
DRUGPatent clopidogrel
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.
Sponsors
Hospital Central San Luis Potosi, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet reactivity change | Day 0 and Day 3 | Change in platelet reactivity measured from day 0 to day 3 of Clopidogrel therapy |
Outcome results
None listed