Genotyping Influences Outcome of Coronary Artery Stenting (GENIUS)
Primary Purpose
Myocardial Ischemia, CLOPIDOGREL, POOR METABOLISM of (Disorder)
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clopidogrel
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Ischemia
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GENIUS
Arm 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
Outcomes
Primary Outcome Measures
Myocardial infarction and Death
Secondary Outcome Measures
Any death
Cardiac death
Myocardial infarction
Stent thrombosis (acute, late, very late)
Target lesion revascularization
Revascularization of in-stent restenosis which developed in previously implanted stent on index procedure
Stroke
Ischemic or hemorrhagic cerebral infarction diagnosed by brain MRI which developed within 1 year after index procedure
Bleeding complication
PRU
Value which is measured with VerifyNow that can monitor platelet inhibition of clopidogrel
ARU
Value which is measured with VerifyNow that can monitor platelet inhibition of aspirin
Full Information
NCT ID
NCT02707445
First Posted
February 23, 2016
Last Updated
March 11, 2016
Sponsor
Korea University Anam Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02707445
Brief Title
Genotyping Influences Outcome of Coronary Artery Stenting
Acronym
GENIUS
Official Title
Prospective Multi-center Registry of Genotyping Related Clopidogrel in Percutaneous Coronary Intervention Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, CLOPIDOGREL, POOR METABOLISM of (Disorder)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GENIUS
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
clopidogrel hydrogen sulfate 97.875mg (75mg as clopidogrel)
Intervention Description
Administration of conventional dual anti-platelet treatment (aspirin 100mg and clopidogrel 75mg daily) for minimum 3 months after percutaneous coronary intervention
Primary Outcome Measure Information:
Title
Myocardial infarction and Death
Time Frame
1 year after index procedure
Secondary Outcome Measure Information:
Title
Any death
Time Frame
1 year after index procedure
Title
Cardiac death
Time Frame
1 year after index procedure
Title
Myocardial infarction
Time Frame
1 year after index procedure
Title
Stent thrombosis (acute, late, very late)
Time Frame
1 year after index procedure
Title
Target lesion revascularization
Description
Revascularization of in-stent restenosis which developed in previously implanted stent on index procedure
Time Frame
1 year after index procedure
Title
Stroke
Description
Ischemic or hemorrhagic cerebral infarction diagnosed by brain MRI which developed within 1 year after index procedure
Time Frame
1 year after index procedure
Title
Bleeding complication
Time Frame
During index procedure
Title
PRU
Description
Value which is measured with VerifyNow that can monitor platelet inhibition of clopidogrel
Time Frame
Within index procedure
Title
ARU
Description
Value which is measured with VerifyNow that can monitor platelet inhibition of aspirin
Time Frame
Within index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do-sun Lim, MD, PhD
Organizational Affiliation
Cardiovascular center, Korea University Anam Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Genotyping Influences Outcome of Coronary Artery Stenting
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