Patent Versus Generic Clopidogrel in Acute Coronary Syndrome

Phase 4

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Generic clopidogrel; Drug: Patent clopidogrel

• Registration Number: NCT02628587
• Lead Sponsor: Hospital Central San Luis Potosi, Mexico

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-12
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-09
• Last Update Submitted: 2015-12-09
• Study First Posted: 2015-12-11
• Last Update Posted: 2015-12-11
• Study Start: 2016-02
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Generic clopidogrel	Generic clopidogrel	Patients are assigned to take generic clopidogrel
Patent clopidogrel	Patent clopidogrel	Patients are assigned to take patent clopidogrel (Plavix)

Primary Outcome Measures

Name	Time	Method
Platelet reactivity change	Day 0 and Day 3	Change in platelet reactivity measured from day 0 to day 3 of Clopidogrel therapy