Comparing clopidogrel and warfarin for preventing strokes in patients with antiphospholipid syndrome
Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE (APS-STROKE)
This study is testing whether clopidogrel or warfarin is better at preventing strokes in adults with antiphospholipid syndrome who have already had a stroke.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 32 sites (Anyang and 31 other locations) |
| Trial ID | NCT05995600 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the effectiveness of clopidogrel-based antiplatelet therapy compared to warfarin for secondary prevention in patients with antiphospholipid syndrome (APS) who have experienced ischemic strokes. The study is a multicenter, prospective, randomized, open, blinded-endpoint trial involving adult patients diagnosed with APS. It seeks to address the limitations of current treatment guidelines, which are based on outdated evidence, by providing high-quality clinical data on the use of antiplatelet drugs in this population. The trial will evaluate the safety and efficacy of these two treatment strategies in preventing further strokes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 years or older with a history of ischemic stroke and a confirmed diagnosis of antiphospholipid syndrome.
Not a fit: Patients with a high-risk antiphospholipid antibody profile or those with conditions that prevent them from discontinuing anticoagulants or antiplatelet agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with antiphospholipid syndrome at risk of stroke.
How similar studies have performed: While there is limited evidence on the use of clopidogrel for APS-related strokes, this study represents a novel approach to addressing a significant gap in current treatment strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Anyang and 31 other locations
- Hallym University Sacred Heart Hospital — Anyang, South Korea (Recruiting)
- Busan Paik Hospital — Busan, South Korea (Recruiting)
- Pusan National University Hospital — Busan, South Korea (Recruiting)
- Chungbuk National University Hospital — Cheongju-si, South Korea (Recruiting)
- Hallym University Chuncheon Sacred Heart Hospital — Chuncheon, South Korea (Recruiting)
- Kangwon National University Hospital — Chuncheon, South Korea (Recruiting)
- Keimyung University Dongsan Medical Center — Daegu, South Korea (Recruiting)
- Yeungnam University Medical Center — Daegu, South Korea (Recruiting)
- Chungnam National University Hospital — Daejeon, South Korea (Recruiting)
- Hanyang University Guri Hospital — Guri-si, South Korea (Recruiting)
- Chonnam National University Hospital — Gwangju, South Korea (Recruiting)
- Chosun University Hospital — Gwangju, South Korea (Recruiting)
- Gachon University Gil Medical Center — Incheon, South Korea (Recruiting)
- Inha University Hospital — Incheon, South Korea (Recruiting)
- Jeju National University Hospital — Jeju City, South Korea (Recruiting)
- Jeonbuk National University Hospital — Jeonju, South Korea (Recruiting)
- Chungnam National University Sejong Hospital — Sejong, South Korea (Recruiting)
- Seoul National University Bundang Hospital — Seongnam, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Chung-Ang University Hospital — Seoul, South Korea (Recruiting)
- Ewha Woman University Seoul Hospital — Seoul, South Korea (Recruiting)
- Ewha Womans University Mokdong Hospital — Seoul, South Korea (Recruiting)
- Hallym University Kangdong Sacred Heart Hospital — Seoul, South Korea (Recruiting)
- Hanyang University Seoul Hospital — Seoul, South Korea (Recruiting)
- Konkuk University Medical Center — Seoul, South Korea (Recruiting)
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
- Kyung Hee University Medical Center — Seoul, South Korea (Recruiting)
- Seoul Metropolitan Government-Seoul National University Boramae Medical Center — Seoul, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Severance Hospital — Seoul, South Korea (Recruiting)
- Uijeongbu Eulji Medical Center — Uijeongbu-si, South Korea (Recruiting)
- Yongin Severance Hospital — Yŏngin, South Korea (Recruiting)
Study contacts
- Principal investigator: Seung-Hoon Lee, MD, PhD — Seoul National University Hospital
- Study coordinator: Wookjin Yang, MD, PhD
- Email: ywj_2002@naver.com
- Phone: +82-2-2072-2114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.