Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE
- Conditions
- Antiphospholipid SyndromeIschemic StrokeTransient Ischemic AttackCerebrovascular DiseaseCardiovascular DiseasesMajor Bleed
- Interventions
- Drug: Antiplatelet Drug
- Registration Number
- NCT05995600
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Antiphospholipid syndrome (APS) has a close association with ischemic stroke; however, the optimal treatment strategy for APS-related stroke has yet to be established. The clinical guidelines suggest using warfarin for APS-related stroke, but these suggestions are largely based on retrospective studies from the 1990s and expert opinion, rather than high-quality clinical trials. Moreover, the evidence on the role of antiplatelet drugs other than aspirin (e.g., clopidogrel) in APS-related stroke is particularly limited. Considering the relatively young age of patients with APS and the high clinical burden of using warfarin, it is necessary to verify whether warfarin is essential. Thus, the investigators aim to compare clopidogrel-based antiplatelet therapy and warfarin as a secondary preventive medication for patients with APS-related stroke. APS-STROKE is an exploratory, multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult patients with definite APS who have a history of ischemic stroke will be included. Patients with high-risk APS (triple positivity or persistently high titers of anti-cardiolipin or anti-β2-glycoprotein I antibodies), systemic lupus erythematous, or indications for continued antiplatelet or anticoagulant therapy will be excluded. Eligible patients will be 1:1 randomized to receive clopidogrel-based antiplatelet therapy or warfarin. Patients assigned to the clopidogrel-based antiplatelet therapy group will be permitted to use additional antiplatelet drugs other than clopidogrel at the investigator's discretion. The primary outcome is a composite of any death, major adverse cardiovascular events, systemic thromboembolic events, and major bleeding during a follow-up period of at least 4 years. This study would provide valuable information for determining the optimal secondary prevention strategy for APS-related stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Age 19 years or older
- 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
- Patients with high-risk antiphospholipid antibody profile (triple positivity; persistent high-titers exceeding 80 U/mL of anti-cardiolipin or anti-β2 glycoprotein I antibodies)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clopidogrel-based antiplatelet therapy group Antiplatelet Drug 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. Warfarin group Warfarin Warfarin (target prothrombin time-international normalized ratio 2.0-3.0)
- Primary Outcome Measures
Name Time Method Composite endpoint 4 years Composite endpoint of any death, major adverse cardiovascular events (MACEs), systemic thromboembolic events, and major bleeding. MACE includes any stroke, transient ischemic attack, and acute coronary syndrome (i.e., ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and hospitalization with unstable angina) in this study. Major bleeding refers to bleeding events meeting the criteria for Bleeding Academic Research Consortium (BARC) type 3 or 5.
- Secondary Outcome Measures
Name Time Method Ischemic stroke 4 years Ischemic stroke or transient ischemic attack
Any bleeding 4 years Major or minor bleeding according to definitions from BARC
Major bleeding 4 years BARC bleeding type 3 or 5
Intracranial bleeding 4 years Intracranial bleeding that is objectively confirmed by brain imaging
MACE 4 years MACE includes any stroke, transient ischemic attack, and acute coronary syndrome (i.e., ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and hospitalization with unstable angina) in this study.
Clinically relevant non-major bleeding 4 years Any bleeding that does not fit the criteria for major bleeding but does meet at least one of the following criteria:
1. requiring nonsurgical, medical intervention by a healthcare professional
2. leading to hospitalization or increased level of care
3. prompting evaluation.Any death 4 years Death from any cause
Thrombosis-related death 4 years Death from arterial, venous, or capillary thrombotic events
Trial Locations
- Locations (32)
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri-si, Korea, Republic of
Jeju National University Hospital
🇰🇷Jeju, Korea, Republic of
Kyung Hee University Medical Center
🇰🇷Seoul, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Hallym University Chuncheon Sacred Heart Hospital
🇰🇷Chuncheon, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Ewha Woman University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Uijeongbu Eulji Medical Center
🇰🇷Uijeongbu, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Yongin Severance Hospital
🇰🇷Yongin, Korea, Republic of
Chungnam National University Sejong Hospital
🇰🇷Sejong, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of