Patent Versus Generic Clopidogrel in Acute Coronary Syndrome

December 9, 2015 updated by: Juan Manuel López Quijano, Hospital Central San Luis Potosi, Mexico

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Generic clopidogrel
Patients are assigned to take generic clopidogrel
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.
Active Comparator: Patent clopidogrel
Patients are assigned to take patent clopidogrel (Plavix)
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.

Other Names:
  • Plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet reactivity change
Time Frame: Day 0 and Day 3
Change in platelet reactivity measured from day 0 to day 3 of Clopidogrel therapy
Day 0 and Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Central San Luis Potosi, Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

December 9, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUZ001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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