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OpenTrials
Completed

NCT Number: NCT02707445

Genotyping Influences Outcome of Coronary Artery Stenting

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.

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Key information

Conditions

Myocardial Ischemia CLOPIDOGREL, POOR METABOLISM of (Disorder) Cardiovascular Diseases Heart Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

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

Other names: clopidogrel hydrogen sulfate 97.875mg (75mg as clopidogrel)

Primary outcomes

  1. Myocardial infarction and Death

    Time frame: 1 year after index procedure

Secondary outcomes

  1. Any death

    Time frame: 1 year after index procedure

  2. Cardiac death

    Time frame: 1 year after index procedure

  3. Myocardial infarction

    Time frame: 1 year after index procedure

  4. Stent thrombosis (acute, late, very late)

    Time frame: 1 year after index procedure

  5. Target lesion revascularization

    Time frame: 1 year after index procedure

    Revascularization of in-stent restenosis which developed in previously implanted stent on index procedure

  6. Stroke

    Time frame: 1 year after index procedure

    Ischemic or hemorrhagic cerebral infarction diagnosed by brain MRI which developed within 1 year after index procedure

  7. Bleeding complication

    Time frame: During index procedure

  8. PRU

    Time frame: Within index procedure

    Value which is measured with VerifyNow that can monitor platelet inhibition of clopidogrel

  9. ARU

    Time frame: Within index procedure

    Value which is measured with VerifyNow that can monitor platelet inhibition of aspirin

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

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

Acronym: GENIUS

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Mar 14, 2016
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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