Genotyping Influences Outcome of Coronary Artery Stenting

Myocardial Ischemia Clinical Trial

— GENIUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707445
• Other study ID #: KUMC-GENIUS
• Status: Completed
• Phase: N/A
• First received: February 23, 2016
• Last updated: March 11, 2016
• Start date: September 2011
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• CLOPIDOGREL, POOR METABOLISM of (Disorder)
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

References & Publications (13)

Angiolillo DJ, Fernandez-Ortiz A, Bernardo E, Alfonso F, Macaya C, Bass TA, Costa MA. Variability in individual responsiveness to clopidogrel: clinical implications, management, and future perspectives. J Am Coll Cardiol. 2007 Apr 10;49(14):1505-16. Epub — View Citation

Bouman HJ, Schömig E, van Werkum JW, Velder J, Hackeng CM, Hirschhäuser C, Waldmann C, Schmalz HG, ten Berg JM, Taubert D. Paraoxonase-1 is a major determinant of clopidogrel efficacy. Nat Med. 2011 Jan;17(1):110-6. doi: 10.1038/nm.2281. Epub 2010 Dec 19. — View Citation

Fontana P, Dupont A, Gandrille S, Bachelot-Loza C, Reny JL, Aiach M, Gaussem P. Adenosine diphosphate-induced platelet aggregation is associated with P2Y12 gene sequence variations in healthy subjects. Circulation. 2003 Aug 26;108(8):989-95. Epub 2003 Aug — View Citation

Fuster V, Stein B, Ambrose JA, Badimon L, Badimon JJ, Chesebro JH. Atherosclerotic plaque rupture and thrombosis. Evolving concepts. Circulation. 1990 Sep;82(3 Suppl):II47-59. Review. — View Citation

Gladding P, White H, Voss J, Ormiston J, Stewart J, Ruygrok P, Bvaldivia B, Baak R, White C, Webster M. Pharmacogenetic testing for clopidogrel using the rapid INFINITI analyzer: a dose-escalation study. JACC Cardiovasc Interv. 2009 Nov;2(11):1095-101. do — View Citation

Luo HR, Poland RE, Lin KM, Wan YJ. Genetic polymorphism of cytochrome P450 2C19 in Mexican Americans: a cross-ethnic comparative study. Clin Pharmacol Ther. 2006 Jul;80(1):33-40. Epub 2006 Jun 8. — View Citation

Mega JL, Simon T, Collet JP, Anderson JL, Antman EM, Bliden K, Cannon CP, Danchin N, Giusti B, Gurbel P, Horne BD, Hulot JS, Kastrati A, Montalescot G, Neumann FJ, Shen L, Sibbing D, Steg PG, Trenk D, Wiviott SD, Sabatine MS. Reduced-function CYP2C19 geno — View Citation

Schömig A. Ticagrelor--is there need for a new player in the antiplatelet-therapy field? N Engl J Med. 2009 Sep 10;361(11):1108-11. doi: 10.1056/NEJMe0906549. Epub 2009 Aug 30. — View Citation

Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Méneveau N, Steg PG, Ferrières J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of respons — View Citation

Storey RF, Newby LJ, Heptinstall S. Effects of P2Y(1) and P2Y(12) receptor antagonists on platelet aggregation induced by different agonists in human whole blood. Platelets. 2001 Nov;12(7):443-7. — View Citation

Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI), Wijns W, Kolh P, Danchin N — View Citation

Trenk D, Hochholzer W, Fromm MF, Chialda LE, Pahl A, Valina CM, Stratz C, Schmiebusch P, Bestehorn HP, Büttner HJ, Neumann FJ. Cytochrome P450 2C19 681G>A polymorphism and high on-clopidogrel platelet reactivity associated with adverse 1-year clinical out — View Citation

Wright RS, Anderson JL, Adams CD, Bridges CR, Casey DE Jr, Ettinger SM, Fesmire FM, Ganiats TG, Jneid H, Lincoff AM, Peterson ED, Philippides GJ, Theroux P, Wenger NK, Zidar JP, Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infarction and Death		1 year after index procedure	Yes
Secondary	Any death		1 year after index procedure	Yes
Secondary	Cardiac death		1 year after index procedure	Yes
Secondary	Myocardial infarction		1 year after index procedure	Yes
Secondary	Stent thrombosis (acute, late, very late)		1 year after index procedure	Yes
Secondary	Target lesion revascularization	Revascularization of in-stent restenosis which developed in previously implanted stent on index procedure	1 year after index procedure	Yes
Secondary	Stroke	Ischemic or hemorrhagic cerebral infarction diagnosed by brain MRI which developed within 1 year after index procedure	1 year after index procedure	Yes
Secondary	Bleeding complication		During index procedure	Yes
Secondary	PRU	Value which is measured with VerifyNow that can monitor platelet inhibition of clopidogrel	Within index procedure	No
Secondary	ARU	Value which is measured with VerifyNow that can monitor platelet inhibition of aspirin	Within index procedure	No