Patent Versus Generic Clopidogrel in Acute Coronary Syndrome

Hospital Central San Luis Potosi, Mexico

Status and phase: Unknown; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Drug: Patent clopidogrel; Drug: Generic clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT02628587

LUZ001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Generic clopidogrel

Experimental group

Description:

Patients are assigned to take generic clopidogrel

Treatment:

Drug: Generic clopidogrel

Patent clopidogrel

Active Comparator group

Description:

Patients are assigned to take patent clopidogrel (Plavix)

Treatment:

Drug: Patent clopidogrel