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Genotyping Influences Outcome of Coronary Artery Stenting

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02707445
Acronym
GENIUS
Enrollment
5000
Registered
2016-03-14
Start date
2011-09-30
Completion date
2016-02-29
Last updated
2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CLOPIDOGREL, POOR METABOLISM of (Disorder), Myocardial Ischemia

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.

Interventions

DRUGClopidogrel

Administration of conventional dual anti-platelet treatment (aspirin 100mg and clopidogrel 75mg daily) for minimum 3 months after percutaneous coronary intervention

Sponsors

Korea University Anam Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Myocardial infarction and Death1 year after index procedure

Secondary

MeasureTime frameDescription
Cardiac death1 year after index procedure
Myocardial infarction1 year after index procedure
Stent thrombosis (acute, late, very late)1 year after index procedure
Target lesion revascularization1 year after index procedureRevascularization of in-stent restenosis which developed in previously implanted stent on index procedure
Any death1 year after index procedure
Bleeding complicationDuring index procedure
PRUWithin index procedureValue which is measured with VerifyNow that can monitor platelet inhibition of clopidogrel
ARUWithin index procedureValue which is measured with VerifyNow that can monitor platelet inhibition of aspirin
Stroke1 year after index procedureIschemic or hemorrhagic cerebral infarction diagnosed by brain MRI which developed within 1 year after index procedure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026