NCT05995600 Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE
| NCT ID | NCT05995600 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Seoul National University Hospital |
| Condition | Antiphospholipid Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2024-02-20 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Seung-Hoon Lee, MD, PhD
PRINCIPAL INVESTIGATOR
Seoul National University Hospital
Frequently Asked Questions
Who can join the NCT05995600 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Antiphospholipid Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05995600 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05995600 currently recruiting?
Yes, NCT05995600 is actively recruiting participants. Contact the research team at ywj_2002@naver.com for enrollment information.
Where is the NCT05995600 trial being conducted?
This trial is being conducted at Anyang, South Korea, Busan, South Korea, Busan, South Korea, Cheongju-si, South Korea and 11 additional locations.
Who is sponsoring the NCT05995600 clinical trial?
NCT05995600 is sponsored by Seoul National University Hospital. The principal investigator is Seung-Hoon Lee, MD, PhD at Seoul National University Hospital. The trial plans to enroll 200 participants.