Status:
RECRUITING
Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Samjin Pharmaceutical Co., Ltd.
Conditions:
Antiphospholipid Syndrome
Ischemic Stroke
Eligibility:
All Genders
19+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05995600
Start Date
February 20 2024
End Date
March 1 2029
Last Update
October 16 2024
Active Locations (32)
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1
Hallym University Sacred Heart Hospital
Anyang, South Korea
2
Busan Paik Hospital
Busan, South Korea
3
Pusan National University Hospital
Busan, South Korea
4
Chungbuk National University Hospital
Cheongju-si, South Korea