Clopidogrel Preventive Effect Based on CYP2C19 Genotype in Ischemic Stroke
NCT ID: NCT04072705
Last Updated: 2023-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2927 participants
OBSERVATIONAL
2019-09-20
2023-07-07
Brief Summary
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Detailed Description
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The researches about cytochrome P450 2C19 genotype and clopidogrel resistance have been conducted mainly in patients with coronary artery disease and are not known in stroke patients. Few studies have examined whether the resistance of clopidogrel according to the genotype of cytochrome P450 2C19 in stroke patients is related to the occurrence and/or recurrence of cardiovascular disease. The hypothesis of this study is that "the poor metabolizer or intermediate metabolizer of the cytochrome P450 2C19 genotype in patients with acute ischemic stroke is associated with increased risk of cardiovascular disease and mortality compared to those who of extensive metabolizer of the cytochrome P450 2C19 genotype".
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1. Poor and intermediate metabolizer group
Poor and intermediate metabolizer group: acute ischemic stroke patients with poor and intermediate metabolizer genotype of cytochrome P450 2C19 for clopidogrel.
General principles of care and judgement of researcher
Because our study will be performed by observational design, there will be no intervention for our study. Because it is a registry-based study, overall decision making for medications will be performed according to the general principles of care and judgement of researcher.
2. Extensive metabolizer group
Extensive metabolizer group: acute ischemic stroke patients with Extensive metabolizer genotype of cytochrome P450 2C19 for clopidogrel.
General principles of care and judgement of researcher
Because our study will be performed by observational design, there will be no intervention for our study. Because it is a registry-based study, overall decision making for medications will be performed according to the general principles of care and judgement of researcher.
Interventions
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General principles of care and judgement of researcher
Because our study will be performed by observational design, there will be no intervention for our study. Because it is a registry-based study, overall decision making for medications will be performed according to the general principles of care and judgement of researcher.
Eligibility Criteria
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Inclusion Criteria
2. Patient who received clopidogrel within 72 hours after onset of ischemic stroke
3. Adults over 19 years
4. Patients who agreed to participate in this study within 7 days after ischemic stroke
5. Patients who underwent Cytochrome P450 2C19 genotype test.
Exclusion Criteria
2. Patients who need other antiplatelet drugs except aspirin and clopidogrel
3. Patients who were taking clopidogrel prior to ischemic stroke
4. Patients scheduled for coronary artery stenting, coronary artery bypass surgery, carotid endarterectomy, carotid and cerebral artery stenting
5. Patients with severe comorbidities or active cancer with an estimated life expectancy of less than two years
6. Patients who participated in other drug clinical trials within the past 30 days
7. Patients with high risk source of potential cardiac source of embolism in TOAST classification
8. Patients who are expected to unable to participate or continue the study
19 Years
ALL
No
Sponsors
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SAMJIN PHARM
UNKNOWN
Gangnam Severance Hospital
OTHER
Responsible Party
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Kyung-Yul Lee
KyungYul Lee, Professor
Principal Investigators
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KyungYul Lee
Role: PRINCIPAL_INVESTIGATOR
Gangnam Severance Hospital
Locations
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Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea
Department of Neurology Korea University Ansan Hospital
Ansan, , South Korea
Department of Neurology Hallym University Sacred Heart Hospital
Anyang, , South Korea
Department of Neurology Inje University Busan Paik Hospital
Busan, , South Korea
Department of Neurology Dong-A University Hospital
Busan, , South Korea
Department of Neurology Kosin University Gospel Hospital
Busan, , South Korea
Department of Neurology Changwon Fatima Hospital
Changwon, , South Korea
Department of Neurology Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, , South Korea
Department of Neurology Kangwon National University Hospital
Chuncheon, , South Korea
Department of Neurology Keimyung University Dongsan Hospital
Daegu, , South Korea
Department of Neurology Kyungpook National University Hospital
Daegu, , South Korea
Department of Neurology Daejeon Eulji Medical Center Eulji University
Daejeon, , South Korea
Department of Neurology Gimpo Woori Hospital
Gimpo-si, , South Korea
Department of Neurology National Health Insurance Service Ilsan Hospital
Goyang, , South Korea
Department of Neurology Myongji Hospital
Goyang, , South Korea
Department of Neurology Chosun University Hospital
Gwangju, , South Korea
Department of Neurology Chonnam National University Hospital
Gwangju, , South Korea
Department of Neurology Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, , South Korea
Department of Neurology Wonkwang University Hospital
Iksan, , South Korea
Department of Neurology Gachon University Gil Medical Center
Incheon, , South Korea
Department of Neurology Inha University Hospital
Incheon, , South Korea
Department of Neurology Catholic Kwandong University International St.Mary's Hospital
Incheon, , South Korea
Department of Neurology Seoul National University Bundang Hospital
Seongnam, , South Korea
Department of Neurology Inje University Sanggye Paik Hospital
Seoul, , South Korea
Department of Neurology Seoul Medical Center
Seoul, , South Korea
Department of Neurology KyungHee University Hospital
Seoul, , South Korea
Department of Neurology Korea University Anam Hospital
Seoul, , South Korea
Department of Neurology Seoul National University Hospital
Seoul, , South Korea
Department of Neurology Severance Hospital, Yonsei University College of Medicine
Seoul, , South Korea
Department of Neurology National Medical Center
Seoul, , South Korea
Department of Neurology Hanyang University Seoul Hospital
Seoul, , South Korea
Department of Neurology KyungHee University Hospital at Gangdong
Seoul, , South Korea
Department of Neurology Kangdong Sacred Heart Hospital
Seoul, , South Korea
Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine
Seoul, , South Korea
Department of Neurology Chung-Ang University Hospital
Seoul, , South Korea
Department of Neurology Ewha Womans University Seoul Hospital
Seoul, , South Korea
Department of Neurology Korea University Guro Hospital
Seoul, , South Korea
Countries
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References
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Mitsios JV, Papathanasiou AI, Rodis FI, Elisaf M, Goudevenos JA, Tselepis AD. Atorvastatin does not affect the antiplatelet potency of clopidogrel when it is administered concomitantly for 5 weeks in patients with acute coronary syndromes. Circulation. 2004 Mar 23;109(11):1335-8. doi: 10.1161/01.CIR.0000124581.18191.15. Epub 2004 Mar 15.
Lau WC, Waskell LA, Watkins PB, Neer CJ, Horowitz K, Hopp AS, Tait AR, Carville DG, Guyer KE, Bates ER. Atorvastatin reduces the ability of clopidogrel to inhibit platelet aggregation: a new drug-drug interaction. Circulation. 2003 Jan 7;107(1):32-7. doi: 10.1161/01.cir.0000047060.60595.cc.
Nguyen TA, Diodati JG, Pharand C. Resistance to clopidogrel: a review of the evidence. J Am Coll Cardiol. 2005 Apr 19;45(8):1157-64. doi: 10.1016/j.jacc.2005.01.034.
Mega JL, Close SL, Wiviott SD, Shen L, Hockett RD, Brandt JT, Walker JR, Antman EM, Macias W, Braunwald E, Sabatine MS. Cytochrome p-450 polymorphisms and response to clopidogrel. N Engl J Med. 2009 Jan 22;360(4):354-62. doi: 10.1056/NEJMoa0809171. Epub 2008 Dec 22.
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.
Collet JP, Hulot JS, Pena A, Villard E, Esteve JB, Silvain J, Payot L, Brugier D, Cayla G, Beygui F, Bensimon G, Funck-Brentano C, Montalescot G. Cytochrome P450 2C19 polymorphism in young patients treated with clopidogrel after myocardial infarction: a cohort study. Lancet. 2009 Jan 24;373(9660):309-17. doi: 10.1016/S0140-6736(08)61845-0. Epub 2008 Dec 26.
Shuldiner AR, O'Connell JR, Bliden KP, Gandhi A, Ryan K, Horenstein RB, Damcott CM, Pakyz R, Tantry US, Gibson Q, Pollin TI, Post W, Parsa A, Mitchell BD, Faraday N, Herzog W, Gurbel PA. Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy. JAMA. 2009 Aug 26;302(8):849-57. doi: 10.1001/jama.2009.1232.
Pan Y, Chen W, Xu Y, Yi X, Han Y, Yang Q, Li X, Huang L, Johnston SC, Zhao X, Liu L, Zhang Q, Wang G, Wang Y, Wang Y. Genetic Polymorphisms and Clopidogrel Efficacy for Acute Ischemic Stroke or Transient Ischemic Attack: A Systematic Review and Meta-Analysis. Circulation. 2017 Jan 3;135(1):21-33. doi: 10.1161/CIRCULATIONAHA.116.024913. Epub 2016 Nov 2.
Han SW, Kim YJ, Ahn SH, Seo WK, Yu S, Oh SH, Nam HS, Choi HY, Yoon SS, Kim SH, Lee JY, Lee JH, Hwang YH, Lee KO, Jung YH, Lee J, Sohn SI, Kim YN, Lee KA, Bushnell CD, Lee KY. Effects of Triflusal and Clopidogrel on the Secondary Prevention of Stroke Based on Cytochrome P450 2C19 Genotyping. J Stroke. 2017 Sep;19(3):356-364. doi: 10.5853/jos.2017.01249. Epub 2017 Sep 29.
Lee SS, Lee SJ, Gwak J, Jung HJ, Thi-Le H, Song IS, Kim EY, Shin JG. Comparisons of CYP2C19 genetic polymorphisms between Korean and Vietnamese populations. Ther Drug Monit. 2007 Aug;29(4):455-9. doi: 10.1097/FTD.0b013e31811f383c.
Wang Y, Zhao X, Lin J, Li H, Johnston SC, Lin Y, Pan Y, Liu L, Wang D, Wang C, Meng X, Xu J, Wang Y; CHANCE investigators. Association Between CYP2C19 Loss-of-Function Allele Status and Efficacy of Clopidogrel for Risk Reduction Among Patients With Minor Stroke or Transient Ischemic Attack. JAMA. 2016 Jul 5;316(1):70-8. doi: 10.1001/jama.2016.8662.
CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet. 1996 Nov 16;348(9038):1329-39. doi: 10.1016/s0140-6736(96)09457-3.
Jung YH, Song TJ, Kim J, Park HK, Han SW, Kim YD, Park JH, Cha JK, Park HY, Sohn SI, Yu S, Lee JH, Shin DH, Kim EG, Lee HS, Lee KY; PLATELET Trial Investigators. Cytochrome P450 2C19 Genotypes and Clopidogrel in Patients With Ischemic Stroke: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e250398. doi: 10.1001/jamanetworkopen.2025.0398.
Song TJ, Kim J, Han SW, Kim YD, Lee JY, Ahn SH, Lee HS, Jung YH, Lee KY. Clopidogrel preventive effect based on cytochrome P450 2C19 genotype in ischaemic stroke: protocol for multicentre observational study. BMJ Open. 2020 Aug 5;10(8):e038031. doi: 10.1136/bmjopen-2020-038031.
Other Identifiers
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3-2019-0195
Identifier Type: -
Identifier Source: org_study_id
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