Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE

Recruiting now · Phase 4

Conditions studied: Antiphospholipid Syndrome, Ischemic Stroke, Transient Ischemic Attack, Cerebrovascular Disease, Cardiovascular Diseases, Major Bleed

In brief

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.

Key facts

Study ID

NCT05995600

Run by

Seoul National University Hospital

People needed

200

Starts

2024-02-20

Expected to finish

2029-03-01

Last updated by the study team

2024-10-16

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Hallym University Sacred Heart Hospital — Anyang, South Korea (enrolling)
• Busan Paik Hospital — Busan, South Korea (enrolling)
• Pusan National University Hospital — Busan, South Korea (enrolling)
• Chungbuk National University Hospital — Cheongju-si, South Korea (enrolling)
• Hallym University Chuncheon Sacred Heart Hospital — Chuncheon, South Korea (enrolling)
• Kangwon National University Hospital — Chuncheon, South Korea (enrolling)
• Keimyung University Dongsan Medical Center — Daegu, South Korea (enrolling)
• Yeungnam University Medical Center — Daegu, South Korea (enrolling)
• Chungnam National University Hospital — Daejeon, South Korea (enrolling)
• Hanyang University Guri Hospital — Guri-si, South Korea (enrolling)
• Chonnam National University Hospital — Gwangju, South Korea (enrolling)
• Chosun University Hospital — Gwangju, South Korea (enrolling)
• Gachon University Gil Medical Center — Incheon, South Korea (enrolling)
• Inha University Hospital — Incheon, South Korea (enrolling)
• Jeju National University Hospital — Jeju City, South Korea (enrolling)
• Jeonbuk National University Hospital — Jeonju, South Korea (enrolling)
• Chungnam National University Sejong Hospital — Sejong, South Korea (enrolling)
• Seoul National University Bundang Hospital — Seongnam, South Korea (enrolling)
• Asan Medical Center — Seoul, South Korea (enrolling)
• Chung-Ang University Hospital — Seoul, South Korea (enrolling)
• Ewha Woman University Seoul Hospital — Seoul, South Korea (enrolling)
• Ewha Womans University Mokdong Hospital — Seoul, South Korea (enrolling)
• Hallym University Kangdong Sacred Heart Hospital — Seoul, South Korea (enrolling)
• Hanyang University Seoul Hospital — Seoul, South Korea (enrolling)
• Konkuk University Medical Center — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.