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

Last updated: October 13, 2024
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Stroke

Circulation Disorders

Vascular Diseases

Treatment

Warfarin

Antiplatelet Drug

Clinical Study ID

NCT05995600
H-2304-096-1425
  • Ages > 19
  • All Genders

Study 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

Inclusion Criteria:

  • Age 19 years or older

  • History of ischemic stroke (cerebral infarction, transient ischemic attack, orretinal 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

Exclusion Criteria:

  • Patients with high-risk antiphospholipid antibody profile (triple positivity;persistent high-titers exceeding 80 U/mL of anti-cardiolipin or anti-β2 glycoproteinI antibodies)

  • Systemic lupus erythematous

  • Patients unable to discontinue previously taken anticoagulants or antiplateletagents (e.g., atrial fibrillation, valvular heart disease, or a history ofpercutaneous coronary intervention)

  • Women who are pregnant, breastfeeding, or intending to become pregnant during thestudy period

  • Deemed unsuitable for participation in the study for more than four years, as perthe investigators' discretion

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Warfarin
Phase: 4
Study Start date:
February 20, 2024
Estimated Completion Date:
March 31, 2029

Connect with a study center

  • Hallym University Sacred Heart Hospital

    Anyang,
    Korea, Republic of

    Active - Recruiting

  • Busan Paik Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju-si,
    Korea, Republic of

    Active - Recruiting

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon,
    Korea, Republic of

    Active - Recruiting

  • Kangwon National University Hospital

    Chuncheon,
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Active - Recruiting

  • Myongji Hospital

    Goyang,
    Korea, Republic of

    Site Not Available

  • National Health Insurance Service Ilsan Hospital

    Goyang,
    Korea, Republic of

    Site Not Available

  • Hanyang University Guri Hospital

    Guri-si,
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hospital

    Gwangju,
    Korea, Republic of

    Active - Recruiting

  • Chosun University Hospital

    Gwangju,
    Korea, Republic of

    Active - Recruiting

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong,
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Inha University Hospital

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Jeju National University Hospital

    Jeju,
    Korea, Republic of

    Active - Recruiting

  • Jeonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Sejong Hospital

    Sejong,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Chung-Ang University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ewha Woman University Seoul Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Hanyang University Seoul Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Konkuk University Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Kyung Hee University Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul Metropolitan Government-Seoul National University Boramae Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Uijeongbu Eulji Medical Center

    Uijeongbu,
    Korea, Republic of

    Active - Recruiting

  • Yongin Severance Hospital

    Yongin,
    Korea, Republic of

    Active - Recruiting

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