Acute Ischemic StrokeNCT04072705
Clopidogrel Preventive Effect Based on CYP2C19 Genotype in Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Gangnam Severance Hospital at 37 sites in South Korea.
Trial summary
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 composite cardiovascular events (recurrent stroke, myocardial infarction, cardiovascular death) compared to those who… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- General principles of care and judgement of researcher
- How many people
- 2,927 participants
- Where
- 37 sitesSouth Korea
- Study dates
- 20 Sep 2019to 7 Jul 2023
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke who received clopidogrel 75 mg to 300 mg (in the case of loading dose) within 24 hours of symptom onset and who underwent Cytochrome P450 2C19 genotyping test
Who may be able to join
- Ischemic stroke confirmed by brain CT or MRI
- Patient who received clopidogrel within 72 hours after onset of ischemic stroke
- Adults over 19 years
- Patients who agreed to participate in this study within 7 days after ischemic stroke
- Patients who underwent Cytochrome P450 2C19 genotype test.
Who cannot join
- Patients who currently take anticoagulation or is expected to take anticoagulation with 6 months from the screening date
- Patients who need other antiplatelet drugs except aspirin and clopidogrel
- Patients who were taking clopidogrel prior to ischemic stroke
- Patients scheduled for coronary artery stenting, coronary artery bypass surgery, carotid endarterectomy, carotid and cerebral artery stenting
- Patients with severe comorbidities or active cancer with an estimated life expectancy of less than two years
- Patients who participated in other drug clinical trials within the past 30 days
- Patients with high risk source of potential cardiac source of embolism in TOAST classification
- Patients who are expected to unable to participate or continue the study
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
South Korea37 sites
Department of Neurology Korea University Ansan Hospital
Ansan, 15355
Department of Neurology Hallym University Sacred Heart Hospital
Anyang, 14068
Department of Neurology Inje University Busan Paik Hospital
Busan, 47392
Department of Neurology Dong-A University Hospital
Busan, 49201
Department of Neurology Kosin University Gospel Hospital
Busan, 49267
Department of Neurology Changwon Fatima Hospital
Changwon, 51394
Department of Neurology Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, 24253
Department of Neurology Kangwon National University Hospital
Chuncheon, 24289
Department of Neurology Keimyung University Dongsan Hospital
Daegu, 41931
Department of Neurology Kyungpook National University Hospital
Daegu, 41944
Department of Neurology Daejeon Eulji Medical Center Eulji University
Daejeon, 35233
Department of Neurology Gimpo Woori Hospital
Gimpo-si, 10099
Department of Neurology National Health Insurance Service Ilsan Hospital
Goyang, 10444
Department of Neurology Myongji Hospital
Goyang, 10475
Department of Neurology Chosun University Hospital
Gwangju, 61453
Department of Neurology Chonnam National University Hospital
Gwangju, 61469
Department of Neurology Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, 18450
Department of Neurology Wonkwang University Hospital
Iksan, 54538
Department of Neurology Gachon University Gil Medical Center
Incheon, 21565
Department of Neurology Inha University Hospital
Incheon, 22332
Department of Neurology Catholic Kwandong University International St.Mary's Hospital
Incheon, 22711
Department of Neurology Seoul National University Bundang Hospital
Seongnam, 13620
Department of Neurology Inje University Sanggye Paik Hospital
Seoul, 01757
Department of Neurology Seoul Medical Center
Seoul, 02053
Department of Neurology KyungHee University Hospital
Seoul, 02447
Department of Neurology Korea University Anam Hospital
Seoul, 02841
Department of Neurology Seoul National University Hospital
Seoul, 03080
Department of Neurology Severance Hospital, Yonsei University College of Medicine
Seoul, 03722
Department of Neurology National Medical Center
Seoul, 04564
Department of Neurology Hanyang University Seoul Hospital
Seoul, 04763
Department of Neurology KyungHee University Hospital at Gangdong
Seoul, 05278
Department of Neurology Kangdong Sacred Heart Hospital
Seoul, 05355
Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine
Seoul, 06273
Department of Neurology Chung-Ang University Hospital
Seoul, 06973
Department of Neurology Ewha Womans University Seoul Hospital
Seoul, 07804
Department of Neurology Korea University Guro Hospital
Seoul, 08308
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, 16995
About this study
Official title: A Multicenter Prospective observationaL Study to evAluate the effecT of Clopidogrel on the prEvention of Major vascuLar Events According to the gEnotype of Cytochrome P450 2C19 in Ischemic Stroke paTients; PLATELET Study
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 composite cardiovascular events (recurrent stroke, myocardial infarction, cardiovascular death) compared to those who of extensive metabolizer of the cytochrome P450 2C19 genotype".
Read the detailed description
Clopidogrel, one of the antiplatelet agents used for secondary prevention in patients with ischemic stroke and coronary artery disease, has been shown to have a superior antiplatelet effect compared to aspirin, and is therefore being administered to many patients with stroke and coronary artery disease. Clopidogrel inhibits platelet-derived ADP receptor, P2Y12, in the liver to produce an anti-platelet effect. It has been suggested that clopidogrel resistance could be occurred from drug-drug interaction via the same pharmacological metabolic pathway. Previous studies reported that the genotypes of Cytochrome P450 2C19, which is involved in the metabolism of clopidogrel in the liver, lead to differences in drug response and recurrence rates of cardiovascular disease. The risk of recurrence of ischemic stroke was reported to be about 4 times higher in patients with a poor metabolizer or intermediate metabolizer genotype of the Cytochrome P450 2C19 genotype compared to the extensive metabolizer genotype. This genotypes of Cytochrome P450 2C19 were also different according to race.
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
- Acute Ischemic Stroke
- Being tested
- General principles of care and judgement of researcher
- Keywords
- Pharmacogenetics, Cytochrome P450 2C19, Clopidogrel, Stroke
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General principles of care and judgement of researcherDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 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. Receives: Drug: General principles of care and judgement of researcher |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite cardiovascular events
Occurrence of composite cardiovascular events (recurrent stroke, myocardial infarction, cardiovascular death)
Measured: up to 6 months
Secondary outcomes (6)
cardiovascular events
Occurrence of ischemic stroke
Measured: up to 6 months
cardiovascular events
Occurrence of transient ischemic attack
Measured: up to 6 months
cardiovascular events
Revascularization of cerebral, coronary, peripheral artery or aorta
Measured: up to 6 months
cardiovascular events
Occurrence of myocardial infarction
Measured: up to 6 months
early neurological worsening
increased National Institutes of Health Stroke Scale within 7 day after admission)
Measured: up to 7 days
Prognosis
ratio of modified Rankin scale (0 - 2) at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start20 Sep 2019
- Primary completion11 Jan 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SAMJIN PHARM
- Responsible party
- Principal investigator, Kyung-Yul Lee, Gangnam Severance Hospital
- Investigators
- KyungYul Lee, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072705
- Sponsor's protocol ID
- 3-2019-0195
- Status last verified
- Sep 2023
- First submitted
- 25 Aug 2019
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 15023882Lau 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.
PubMed 12515739Nguyen 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.
PubMed 15837243Mega 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.
PubMed 19106084Simon 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 19106083Collet 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.
PubMed 19108880Shuldiner 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.
PubMed 19706858Pan 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.
PubMed 27806998Han 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.
PubMed 29037010Lee 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.
PubMed 17667801Wang 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.
PubMed 27348249CAPRIE 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.
PubMed 8918275Park H, Lee HS, Jung YH, Jeon S, 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 KY, Song TJ; PLATELET Trial Investigators. Association of cytochrome P450 2C19 genotypes with effectiveness of clopidogrel in ischemic stroke by smoking status. Sci Rep. 2026 Jul 2. doi: 10.1038/s41598-026-59902-z. Online ahead of print.
PubMed 42393145Jung 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.
PubMed 40184070Song 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.
PubMed 32759249
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective observationaL Study to evAluate the effecT of Clopidogrel on the prEvention of Major vascuLar Events According to the gEnotype of Cytochrome P450 2C19 in Ischemic Stroke paTients; PLATELET Study
- ClinicalTrials.gov ID
- NCT04072705
- Acronym / sponsor ID
- 3-2019-0195
- Conditions
- Acute Ischemic Stroke
- Keywords
- Pharmacogenetics, Cytochrome P450 2C19, Clopidogrel, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,927 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Collaborators
- SAMJIN PHARM
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 composite cardiovascular events (recurrent stroke, myocardial infarction, cardiovascular death) compared to those who of extensive metabolizer of the cytochrome P450 2C19 genotype".
Detailed description
Clopidogrel, one of the antiplatelet agents used for secondary prevention in patients with ischemic stroke and coronary artery disease, has been shown to have a superior antiplatelet effect compared to aspirin, and is therefore being administered to many patients with stroke and coronary artery disease. Clopidogrel inhibits platelet-derived ADP receptor, P2Y12, in the liver to produce an anti-platelet effect. It has been suggested that clopidogrel resistance could be occurred from drug-drug interaction via the same pharmacological metabolic pathway. Previous studies reported that the genotypes of Cytochrome P450 2C19, which is involved in the metabolism of clopidogrel in the liver, lead to differences in drug response and recurrence rates of cardiovascular disease. The risk of recurrence of ischemic stroke was reported to be about 4 times higher in patients with a poor metabolizer or intermediate metabolizer genotype of the Cytochrome P450 2C19 genotype compared to the extensive metabolizer genotype. This genotypes of Cytochrome P450 2C19 were also different according to race.
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".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Poor and intermediate metabolizer group | – | Drug: General principles of care and judgement of researcherPoor and intermediate metabolizer group: acute ischemic stroke patients with poor and intermediate metabolizer genotype of cytochrome P450 2C19 for clopidogrel. |
| 2. Extensive metabolizer group | – | Drug: General principles of care and judgement of researcherExtensive metabolizer group: acute ischemic stroke patients with Extensive metabolizer genotype of cytochrome P450 2C19 for clopidogrel. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke who received clopidogrel 75 mg to 300 mg (in the case of loading dose) within 24 hours of symptom onset and who underwent Cytochrome P450 2C19 genotyping test
Key inclusion criteria (5 listed)
- Ischemic stroke confirmed by brain CT or MRI
- Patient who received clopidogrel within 72 hours after onset of ischemic stroke
- Adults over 19 years
- Patients who agreed to participate in this study within 7 days after ischemic stroke
- Patients who underwent Cytochrome P450 2C19 genotype test.
Key exclusion criteria (8 listed)
- Patients who currently take anticoagulation or is expected to take anticoagulation with 6 months from the screening date
- Patients who need other antiplatelet drugs except aspirin and clopidogrel
- Patients who were taking clopidogrel prior to ischemic stroke
- Patients scheduled for coronary artery stenting, coronary artery bypass surgery, carotid endarterectomy, carotid and cerebral artery stenting
- Patients with severe comorbidities or active cancer with an estimated life expectancy of less than two years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General principles of care and judgement of researcherBecause 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. | Drug | 1. Poor and intermediate metabolizer group, 2. Extensive metabolizer group |
Primary outcome
composite cardiovascular events
Time frame: up to 6 months
Occurrence of composite cardiovascular events (recurrent stroke, myocardial infarction, cardiovascular death)
6 secondary outcomes
cardiovascular events
Time frame: up to 6 months
cardiovascular events
Time frame: up to 6 months
cardiovascular events
Time frame: up to 6 months
cardiovascular events
Time frame: up to 6 months
early neurological worsening
Time frame: up to 7 days
Prognosis
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Background: PubMed 15023882Mitsios 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.
- Background: PubMed 12515739Lau 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.
- Background: PubMed 15837243Nguyen 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.
- Background: PubMed 19106084Mega 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.
- Background: PubMed 19106083Simon 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.
- Background: PubMed 19108880Collet 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.
- Background: PubMed 19706858Shuldiner 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.
- Background: PubMed 27806998Pan 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.
- Background: PubMed 29037010Han 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.
- Background: PubMed 17667801Lee 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.
- Background: PubMed 27348249Wang 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.
- Background: PubMed 8918275CAPRIE 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.
Related trials for Acute Ischemic Stroke
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Recruiting
Safety and Feasibility of NRICM301 Added to Usual Care for Adults With Acute Ischemic Stroke
Acute Ischemic Stroke
Not yet recruitingObservational study
Tenecteplase in Acute Ischemic Stroke Under Different Transfer Models
Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KyungYul Lee principal investigator
Gangnam Severance Hospital
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Gangnam Severance Hospital at 37 sites in South Korea.
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 5 inclusion and 8 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 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
composite cardiovascular events (time frame: up to 6 months). 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 NCT04072705, which also lists 15 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 25 Sep 2023.