Clinical trial NCT02707445: Genotyping Influences Outcome of Coronary Artery Stenting
Official title: Prospective Multi-center Registry of Genotyping Related Clopidogrel in Percutaneous Coronary Intervention Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
CLOPIDOGREL, POOR METABOLISM of (Disorder)
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Myocardial infarction and Death
timeFrame: 1 year after index procedure
Secondary outcomes:
measure: Any death
timeFrame: 1 year after index procedure
measure: Cardiac death
timeFrame: 1 year after index procedure
measure: Myocardial infarction
timeFrame: 1 year after index procedure
measure: Stent thrombosis (acute, late, very late)
timeFrame: 1 year after index procedure
measure: Target lesion revascularization
timeFrame: 1 year after index procedure
measure: Stroke
timeFrame: 1 year after index procedure
measure: Bleeding complication
timeFrame: During index procedure
measure: PRU
timeFrame: Within index procedure
measure: ARU
timeFrame: Within index procedure
Other outcomes:
Locations:
Study officials:
affiliation: Cardiovascular center, Korea University Anam Hospital
name: Do-sun Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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