Acute Ischemic Stroke Clinical Trial
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
NCT number | NCT04072705 |
Other study ID # | 3-2019-0195 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 20, 2019 |
Est. completion date | July 7, 2023 |
Verified date | September 2023 |
Source | Gangnam Severance Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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".
Status | Completed |
Enrollment | 2927 |
Est. completion date | July 7, 2023 |
Est. primary completion date | January 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: 1. Ischemic stroke confirmed by brain CT or MRI 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: 1. Patients who currently take anticoagulation or is expected to take anticoagulation with 6 months from the screening date 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Neurology Korea University Ansan Hospital | Ansan | |
Korea, Republic of | Department of Neurology Hallym University Sacred Heart Hospital | Anyang | |
Korea, Republic of | Department of Neurology Dong-A University Hospital | Busan | |
Korea, Republic of | Department of Neurology Inje University Busan Paik Hospital | Busan | |
Korea, Republic of | Department of Neurology Kosin University Gospel Hospital | Busan | |
Korea, Republic of | Department of Neurology Changwon Fatima Hospital | Changwon | |
Korea, Republic of | Department of Neurology Hallym University Chuncheon Sacred Heart Hospital | Chuncheon | |
Korea, Republic of | Department of Neurology Kangwon National University Hospital | Chuncheon | |
Korea, Republic of | Department of Neurology Keimyung University Dongsan Hospital | Daegu | |
Korea, Republic of | Department of Neurology Kyungpook National University Hospital | Daegu | |
Korea, Republic of | Department of Neurology Daejeon Eulji Medical Center Eulji University | Daejeon | |
Korea, Republic of | Department of Neurology Gimpo Woori Hospital | Gimpo-si | |
Korea, Republic of | Department of Neurology Myongji Hospital | Goyang | |
Korea, Republic of | Department of Neurology National Health Insurance Service Ilsan Hospital | Goyang | |
Korea, Republic of | Department of Neurology Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Department of Neurology Chosun University Hospital | Gwangju | |
Korea, Republic of | Department of Neurology Hallym University Dongtan Sacred Heart Hospital | Hwaseong-si | |
Korea, Republic of | Department of Neurology Wonkwang University Hospital | Iksan | |
Korea, Republic of | Department of Neurology Catholic Kwandong University International St.Mary's Hospital | Incheon | |
Korea, Republic of | Department of Neurology Gachon University Gil Medical Center | Incheon | |
Korea, Republic of | Department of Neurology Inha University Hospital | Incheon | |
Korea, Republic of | Department of Neurology Seoul National University Bundang Hospital | Seongnam | |
Korea, Republic of | Department of Neurology Chung-Ang University Hospital | Seoul | |
Korea, Republic of | Department of Neurology Ewha Womans University Seoul Hospital | Seoul | |
Korea, Republic of | Department of Neurology Hanyang University Seoul Hospital | Seoul | |
Korea, Republic of | Department of Neurology Inje University Sanggye Paik Hospital | Seoul | |
Korea, Republic of | Department of Neurology Kangdong Sacred Heart Hospital | Seoul | |
Korea, Republic of | Department of Neurology Korea University Anam Hospital | Seoul | |
Korea, Republic of | Department of Neurology Korea University Guro Hospital | Seoul | |
Korea, Republic of | Department of Neurology KyungHee University Hospital | Seoul | |
Korea, Republic of | Department of Neurology KyungHee University Hospital at Gangdong | Seoul | |
Korea, Republic of | Department of Neurology National Medical Center | Seoul | |
Korea, Republic of | Department of Neurology Seoul Medical Center | Seoul | |
Korea, Republic of | Department of Neurology Seoul National University Hospital | Seoul | |
Korea, Republic of | Department of Neurology Severance Hospital, Yonsei University College of Medicine | Seoul | |
Korea, Republic of | Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine | Seoul | |
Korea, Republic of | Yongin Severance Hospital | Yongin-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Gangnam Severance Hospital | SAMJIN PHARM |
Korea, Republic of,
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. — View Citation
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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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of major adverse events | Occurrence of major bleeding (fatal bleeding, symptomatic cerebral hemorrhage, ocular hemorrhage, bleeding which needs absolute bed rest or hospitalization or transfusion (more than 2 pack of whole blood or RBC). Occurrence of all-causes mortality |
Tile frame: participants will be followed at 0, 1, 3, 6 months | |
Primary | composite cardiovascular events | Occurrence of composite cardiovascular events (recurrent stroke, myocardial infarction, cardiovascular death) | up to 6 months | |
Secondary | cardiovascular events | Occurrence of ischemic stroke | up to 6 months | |
Secondary | cardiovascular events | Occurrence of transient ischemic attack | up to 6 months | |
Secondary | cardiovascular events | Revascularization of cerebral, coronary, peripheral artery or aorta | up to 6 months | |
Secondary | cardiovascular events | Occurrence of myocardial infarction | up to 6 months | |
Secondary | early neurological worsening | increased National Institutes of Health Stroke Scale within 7 day after admission) | up to 7 days | |
Secondary | Prognosis | ratio of modified Rankin scale (0 - 2) at 3 months | 3 months |
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