Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE
NCT ID: NCT05995600
Last Updated: 2024-10-16
Study Results
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Basic Information
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RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2024-02-20
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Clopidogrel-based antiplatelet therapy group
Clopidogrel 75 mg daily
Patients assigned to this group will be permitted to use additional antiplatelet drugs other than clopidogrel at the investigator's discretion.
Antiplatelet Drug
Clopidogrel ± other antiplatelet drug
Warfarin group
Warfarin (target prothrombin time-international normalized ratio 2.0-3.0)
Warfarin
Warfarin (target prothrombin time-international normalized ratio 2.0-3.0)
Interventions
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Antiplatelet Drug
Clopidogrel ± other antiplatelet drug
Warfarin
Warfarin (target prothrombin time-international normalized ratio 2.0-3.0)
Eligibility Criteria
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Inclusion Criteria
* History of ischemic stroke (cerebral infarction, transient ischemic attack, or retinal arterial ischemic event)
* Patients who meet the laboratory diagnostic criteria for antiphospholipid syndrome (APS)
* Patients or guardians who agree to the study protocol and sign with informed consent
Exclusion Criteria
* Systemic lupus erythematous
* Patients unable to discontinue previously taken anticoagulants or antiplatelet agents (e.g., atrial fibrillation, valvular heart disease, or a history of percutaneous coronary intervention)
* Women who are pregnant, breastfeeding, or intending to become pregnant during the study period
* Deemed unsuitable for participation in the study for more than four years, as per the investigators' discretion
19 Years
ALL
No
Sponsors
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Samjin Pharmaceutical Co., Ltd.
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Seung-Hoon Lee
Professor
Principal Investigators
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Seung-Hoon Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Hallym University Sacred Heart Hospital
Anyang, , South Korea
Busan Paik Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Hanyang University Guri Hospital
Guri-si, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Chungnam National University Sejong Hospital
Sejong, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Ewha Woman University Seoul Hospital
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Hallym University Kangdong Sacred Heart Hospital
Seoul, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Kyung Hee University Medical Center
Seoul, , South Korea
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Uijeongbu Eulji Medical Center
Uijeongbu-si, , South Korea
Yongin Severance Hospital
Yŏngin, , South Korea
Countries
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Central Contacts
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References
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Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
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Kaatz S, Ahmad D, Spyropoulos AC, Schulman S; Subcommittee on Control of Anticoagulation. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015 Nov;13(11):2119-26. doi: 10.1111/jth.13140. No abstract available.
Other Identifiers
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H-2304-096-1425
Identifier Type: -
Identifier Source: org_study_id
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