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Clinical Trials/NCT02628587
NCT02628587
Unknown
Phase 4

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

Hospital Central San Luis Potosi, Mexico0 sites60 target enrollmentFebruary 2016

Overview

Phase
Phase 4
Intervention
Generic clopidogrel
Conditions
Acute Coronary Syndrome
Sponsor
Hospital Central San Luis Potosi, Mexico
Enrollment
60
Primary Endpoint
Platelet reactivity change
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
June 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital Central San Luis Potosi, Mexico
Responsible Party
Principal Investigator
Principal Investigator

Juan Manuel López Quijano

Dr. Juan Manuel Lopez Quijano

Hospital Central San Luis Potosi, Mexico

Eligibility Criteria

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

Arms & Interventions

Generic clopidogrel

Patients are assigned to take generic clopidogrel

Intervention: Generic clopidogrel

Patent clopidogrel

Patients are assigned to take patent clopidogrel (Plavix)

Intervention: Patent clopidogrel

Outcomes

Primary Outcomes

Platelet reactivity change

Time Frame: Day 0 and Day 3

Change in platelet reactivity measured from day 0 to day 3 of Clopidogrel therapy

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