Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE
Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Aug 9, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness of two different medications—clopidogrel-based antiplatelet therapy and warfarin—for preventing strokes in patients with antiphospholipid syndrome (APS). APS is a condition that can increase the risk of blood clots, leading to strokes. Currently, guidelines recommend using warfarin for people with APS who have had a stroke, but there isn't enough recent research to confidently support this approach. The trial aims to find out whether clopidogrel, which is another type of medication that helps prevent blood clots, might be a better option.
To participate in this study, you need to be at least 19 years old and have a history of ischemic stroke, which means your stroke was caused by a blockage in a blood vessel supplying the brain. You also must meet specific laboratory criteria for APS. However, if you have certain high-risk factors or other medical conditions, you may not be eligible. If you join the trial, you'll be randomly assigned to receive either clopidogrel or warfarin for at least four years. Researchers will closely monitor your health to see which treatment is more effective and safer in preventing serious health issues like another stroke or major bleeding. This study could help determine the best way to manage stroke risk in patients with APS.
Gender
ALL
Eligibility 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
About Seoul National University Hospital
Seoul National University Hospital (SNUH) is a leading medical institution in South Korea, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, SNUH integrates cutting-edge scientific inquiry with patient-centered care, facilitating the development of novel therapies and treatment protocols. The hospital boasts a diverse range of specialized departments and a robust infrastructure for conducting clinical studies, ensuring rigorous adherence to ethical standards and regulatory compliance. By fostering collaboration among multidisciplinary teams, SNUH aims to contribute significantly to global medical advancements and improve patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Incheon, , Korea, Republic Of
Seongnam, , Korea, Republic Of
Seoul, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Jeonju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Incheon, , Korea, Republic Of
Busan, , Korea, Republic Of
Chuncheon, , Korea, Republic Of
Jeju, , Korea, Republic Of
Daegu, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Anyang, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Busan, , Korea, Republic Of
Seoul, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Goyang, , Korea, Republic Of
Cheongju Si, , Korea, Republic Of
Cheongju Si, Chungcheongbuk Do, Korea, Republic Of
Chuncheon, , Korea, Republic Of
Sejong, , Korea, Republic Of
Guri Si, , Korea, Republic Of
Goyang, , Korea, Republic Of
Seongnam, Gyeonggi Do, Korea, Republic Of
Yongin, , Korea, Republic Of
Gwangmyeong, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Uijeongbu, , Korea, Republic Of
Patients applied
Trial Officials
Seung-Hoon Lee, MD, PhD
Principal Investigator
Seoul National University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported