Patent Versus Generic Clopidogrel in Acute Coronary Syndrome

NCT02628587 | Unknown Phase 4

• 1 other identifier: LUZ001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity change

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

  Day 0 and Day 3

Study Arms (2)

Generic clopidogrel

EXPERIMENTAL

Patients are assigned to take generic clopidogrel

Drug: Generic clopidogrel

Patent clopidogrel

ACTIVE COMPARATOR

Patients are assigned to take patent clopidogrel (Plavix)

Drug: Patent clopidogrel

Interventions

Generic clopidogrel 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.

Generic clopidogrel

Patent clopidogrel 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.

Also known as: Plavix

Patent clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Central San Luis Potosi, Mexico: lead

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Juan Manuel Lopez Quijano

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 11, 2015
• Study Start: February 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 11, 2015

Record last verified: 2015-12