Genotyping Influences Outcome of Coronary Artery Stenting

Study Overview
=================
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.

Official Title
-----------------
Prospective Multi-center Registry of Genotyping Related Clopidogrel in Percutaneous Coronary Intervention Patients

Conditions
-----------------
Myocardial Ischemia, CLOPIDOGREL, POOR METABOLISM of (Disorder)

Intervention / Treatment
-----------------
* Drug: Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GENIUS<br>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 | Drug: Clopidogrel<br>* Administration of conventional dual anti-platelet treatment (aspirin 100mg and clopidogrel 75mg daily) for minimum 3 months after percutaneous coronary intervention<br>* Other names: clopidogrel hydrogen sulfate 97.875mg (75mg as clopidogrel);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction and Death |  | 1 year after index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Revascularization of in-stent restenosis which developed in previously implanted stent on index procedure | 1 year after index procedure | 
| Stroke | Ischemic or hemorrhagic cerebral infarction diagnosed by brain MRI which developed within 1 year after index procedure | 1 year after index procedure | 
| Bleeding complication |  | During index procedure | 
| PRU | Value which is measured with VerifyNow that can monitor platelet inhibition of clopidogrel | Within index procedure | 
| ARU | Value which is measured with VerifyNow that can monitor platelet inhibition of aspirin | Within index procedure |