Genotyping Influences Outcome of Coronary Artery Stenting

Not Applicable

Completed

• Conditions: CLOPIDOGREL, POOR METABOLISM of (Disorder); Myocardial Ischemia
• Interventions: Drug: Clopidogrel

• Registration Number: NCT02707445
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

This study evaluated epidemiology and clinical outcome of clopidogrel related various genotyping in Korean patients who had undergone percutaneous coronary intervention as a all comer registry form.

Detailed Description

This study evaluates the relationship between clopidogrel related various genotyping, epidemiology and clinical outcome of patient who had undergone percutaneous coronary intervention. Clopidogrel resistance was measured with VerifyNow, which is a device that can monitor platelet inhibition of clopidogrel. Genes which are known to be related with clopidogrel resistance were evaluated; (1-3) CYP 2C19 \*2, \*3, \*17, (4) PON1 Q192R, (5) ABCB1 3435C-\>T, (6) P2Y12, (7) CYP 2C9 \*3.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2016-02-23
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-11
• Last Update Submitted: 2016-03-11
• Study First Posted: 2016-03-14
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Written informed consent
• Older than 20 years
• All percutaneous coronary intervention patients within 1 month

Exclusion Criteria

• Pregnancy
• Life expectancy below 1 year
• Known aspirin or clopidogrel allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GENIUS	Clopidogrel	All comer patients who had undergone percutaneous coronary intervention with administration of conventional dual anti-platelet treatment (aspirin 100mg and clopidogrel 75mg daily) for minimum 3 months

Primary Outcome Measures

Name	Time	Method
Myocardial infarction and Death	1 year after index procedure

Secondary Outcome Measures

Name	Time	Method
Any death	1 year after index procedure
Cardiac death	1 year after index procedure
Myocardial infarction	1 year after index procedure
Stent thrombosis (acute, late, very late)	1 year after index procedure
Target lesion revascularization	1 year after index procedure	Revascularization of in-stent restenosis which developed in previously implanted stent on index procedure
Stroke	1 year after index procedure	Ischemic or hemorrhagic cerebral infarction diagnosed by brain MRI which developed within 1 year after index procedure
Bleeding complication	During index procedure
PRU	Within index procedure	Value which is measured with VerifyNow that can monitor platelet inhibition of clopidogrel
ARU	Within index procedure	Value which is measured with VerifyNow that can monitor platelet inhibition of aspirin