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The Influence of CYP2C19 Polymorphism and Clinical Outcomes in Stroke Patients

NCT02711410 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 518

Last updated 2016-03-18

No results posted yet for this study

Summary

Background:

Clopidogrel, an antiplatelet prodrug, is widely used for prevention of the recurrent cardiovascular events. CYP2C19 is one of the crucial enzymes for the activation of clopidogrel. Recent studies, mostly done in cardiovascular patients, showed association of the CYP2C19 genotypes with recurrent cardiovascular events. However, prospective data on the impact of the genetic variants in stroke patients are limited.

Methods:

Five hundred and eighteen Japanese non-acute stroke patients treated with clopidogrel were registered at 14 institutions. Three CYP2C19 variants (CYP2C19\*2, \*3, \*17) were genotyped and the patients were classified into three clopidogrel metabolizer groups inferred from the CYP2C19 genotypes: extensive (EM: \*1/\*1), intermediate (IM: \*1/\*2 or \*1/\*3), and poor (PM: \*2/\*2, \*2/\*3, or \*3/\*3). The CYP2C19\*17 carriers were excluded from the analysis. The antiplatelet effects of clopidogrel were assessed by Adenosine diphosphate (ADP) -induced platelet aggregation and vasodilator-stimulated phosphoprotein (VASP) phosphorylation, expressed as VASP index. The endpoint was the composite incidence of stroke, transient ischemic attack, myocardial infarction, revascularization, other thromboembolic disease, or cardiovascular death during 2 years of follow-up.

Conditions

  • Platelet Aggregation Inhibitors

Interventions

DRUG

Clopidogrel

Sponsors & Collaborators

  • National Cerebral and Cardiovascular Center, Japan

    lead OTHER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-04-30
Completion
2015-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02711410 on ClinicalTrials.gov