Genotyping Influences Outcome of Coronary Artery Stenting (GENIUS)

Korea University

Status: Completed

Conditions: Myocardial Ischemia; CLOPIDOGREL, POOR METABOLISM of (Disorder)

Treatments: Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT02707445

KUMC-GENIUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5,000 participants in 1 patient group

GENIUS

Experimental group

Description:

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

Treatment:

Drug: Clopidogrel