AzTrials
AzTrials

Myocardial IschemiaGENIUSNCT02707445

Genotyping Influences Outcome of Coronary Artery Stenting

A study testing Clopidogrel in people with Myocardial Ischemia and CLOPIDOGREL, POOR METABOLISM of (Disorder), run by Korea University Anam Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Clopidogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,000 participants
Where
No sites listed yet
Study dates
Sep 2011to Feb 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Older than 20 years
  • All percutaneous coronary intervention patients within 1 month

Who cannot join

  • Pregnancy
  • Life expectancy below 1 year
  • Known aspirin or clopidogrel allergy

About this study

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

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.

Read the 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.

Being tested
Clopidogrel
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClopidogrelDrug

    Also called clopidogrel hydrogen sulfate 97.875mg (75mg as clopidogrel)

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

Study groups in NCT02707445
Study groupRoleWhat they receive
GENIUSExperimentalAll 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
Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial infarction and Death

    Measured: 1 year after index procedure

Secondary outcomes (9)

  1. Any death

    Measured: 1 year after index procedure

  2. Cardiac death

    Measured: 1 year after index procedure

  3. Myocardial infarction

    Measured: 1 year after index procedure

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

    Measured: 1 year after index procedure

  5. Target lesion revascularization

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

    Measured: 1 year after index procedure

  6. Stroke

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

    Measured: 1 year after index procedure

  7. Bleeding complication

    Measured: During index procedure

  8. PRU

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

    Measured: Within index procedure

  9. ARU

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

    Measured: Within index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2016 (estimated)
  2. Study startSep 2011
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02707445
Sponsor's protocol ID
KUMC-GENIUS
Acronym
GENIUS
Status last verified
Mar 2016
First submitted
23 Feb 2016
Last updated
14 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 2203564

  • 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. doi: 10.1080/09537100120085450.

    PubMed 11674863

  • 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. doi: 10.1016/j.jacc.2006.11.044. Epub 2007 Mar 26.

    PubMed 17418288

  • 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, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010 Oct;31(20):2501-55. doi: 10.1093/eurheartj/ehq277. Epub 2010 Aug 29. No abstract available.

    PubMed 20802248

  • 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 WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS. 2011 ACCF/AHA focused update of the Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction (updating the 2007 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 May 10;57(19):1920-59. doi: 10.1016/j.jacc.2011.02.009. Epub 2011 Mar 28. No abstract available.

    PubMed 21450428

  • Schomig 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. No abstract available.

    PubMed 19717845

  • Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Meneveau N, Steg PG, Ferrieres J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.

    PubMed 19106083

  • 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 genotype and risk of adverse clinical outcomes among patients treated with clopidogrel predominantly for PCI: a meta-analysis. JAMA. 2010 Oct 27;304(16):1821-30. doi: 10.1001/jama.2010.1543.

    PubMed 20978260

  • Bouman HJ, Schomig E, van Werkum JW, Velder J, Hackeng CM, Hirschhauser 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.

    PubMed 21170047

  • 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. doi: 10.1016/j.jcin.2009.08.018.

    PubMed 19926050

  • 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. doi: 10.1161/01.CIR.0000085073.69189.88. Epub 2003 Aug 11.

    PubMed 12912815

  • 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. doi: 10.1016/j.clpt.2006.03.003. Epub 2006 Jun 8.

    PubMed 16815315

  • Trenk D, Hochholzer W, Fromm MF, Chialda LE, Pahl A, Valina CM, Stratz C, Schmiebusch P, Bestehorn HP, Buttner HJ, Neumann FJ. Cytochrome P450 2C19 681G>A polymorphism and high on-clopidogrel platelet reactivity associated with adverse 1-year clinical outcome of elective percutaneous coronary intervention with drug-eluting or bare-metal stents. J Am Coll Cardiol. 2008 May 20;51(20):1925-34. doi: 10.1016/j.jacc.2007.12.056.

    PubMed 18482659

  • Cha JJ, Joo HJ, Park JH, Hong SJ, Ahn TH, Kim BK, Shin W, Ahn SG, Yoon J, Kim YH, Cho YH, Kang WC, Kim W, Lim YH, Gwon H, Choi W, Lim DS. Impact of genetic variants on major bleeding after percutaneous coronary intervention based on a prospective multicenter registry. Sci Rep. 2021 Jan 19;11(1):1790. doi: 10.1038/s41598-020-80319-9.

    PubMed 33469058

Questions about this trial

What is this clinical trial studying?

A study testing Clopidogrel in people with Myocardial Ischemia and CLOPIDOGREL, POOR METABOLISM of (Disorder), run by Korea University Anam Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial infarction and Death (time frame: 1 year after index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02707445, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in