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Patent Versus Generic Clopidogrel in Acute Coronary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02628587
Recruitment Status : Unknown
Verified December 2015 by Juan Manuel López Quijano, Hospital Central San Luis Potosi, Mexico.
Recruitment status was:  Not yet recruiting
First Posted : December 11, 2015
Last Update Posted : December 11, 2015
Information provided by (Responsible Party):
Juan Manuel López Quijano, Hospital Central San Luis Potosi, Mexico

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Generic clopidogrel Drug: Patent clopidogrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Platelet Reactivity in Patients With Acute Coronary Syndrome Given Patent Clopidogrel Versus Generic Clopidogrel: Randomized Controlled Trial
Study Start Date : February 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

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 Name: Plavix

Primary Outcome Measures :
  1. Platelet reactivity change [ Time Frame: Day 0 and Day 3 ]
    Change in platelet reactivity measured from day 0 to day 3 of Clopidogrel therapy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: Juan Manuel López Quijano, Dr. Juan Manuel Lopez Quijano, Hospital Central San Luis Potosi, Mexico Identifier: NCT02628587     History of Changes
Other Study ID Numbers: LUZ001
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Juan Manuel López Quijano, Hospital Central San Luis Potosi, Mexico:
Acute Coronary Syndrome
Platelet reactivity
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs