Patent Versus Generic Clopidogrel in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02628587
• Other study ID #: LUZ001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 9, 2015
• Last updated: December 9, 2015
• Start date: February 2016
• Est. completion date: June 2016

Study information

• Verified date: December 2015
• Source: Hospital Central San Luis Potosi, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Central San Luis Potosi, Mexico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet reactivity change	Change in platelet reactivity measured from day 0 to day 3 of Clopidogrel therapy	Day 0 and Day 3	Yes