Patent Versus Generic Clopidogrel in Acute Coronary Syndrome

NCT ID: NCT02628587

Last Updated: 2015-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-06-30

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome; Clopidogrel; Platelet reactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Generic clopidogrel

Patients are assigned to take generic clopidogrel

Group Type: EXPERIMENTAL

Generic clopidogrel

Intervention Type: DRUG

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.

Patent clopidogrel

Patients are assigned to take patent clopidogrel (Plavix)

Group Type: ACTIVE_COMPARATOR

Patent clopidogrel

Intervention Type: DRUG

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.

Interventions

Generic 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.

Intervention Type: DRUG

Patent 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.

Intervention Type: DRUG

Other Intervention Names

Plavix

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Central San Luis Potosi, Mexico

OTHER

Sponsor Role: lead

Responsible Party

Juan Manuel López Quijano

Dr. Juan Manuel Lopez Quijano

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

LUZ001

Identifier Type: -

Identifier Source: org_study_id