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

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Hallym University Sacred Heart Hospital
RECRUITING
Anyang
Busan Paik Hospital
RECRUITING
Busan
Pusan National University Hospital
RECRUITING
Busan
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Hallym University Chuncheon Sacred Heart Hospital
RECRUITING
Chuncheon
Kangwon National University Hospital
RECRUITING
Chuncheon
Keimyung University Dongsan Medical Center
RECRUITING
Daegu
Yeungnam University Medical Center
RECRUITING
Daegu
Chungnam National University Hospital
RECRUITING
Daejeon
Hanyang University Guri Hospital
RECRUITING
Guri-si
Chonnam National University Hospital
RECRUITING
Gwangju
Chosun University Hospital
RECRUITING
Gwangju
Gachon University Gil Medical Center
RECRUITING
Incheon
Inha University Hospital
RECRUITING
Incheon
Jeju National University Hospital
RECRUITING
Jeju City
Jeonbuk National University Hospital
RECRUITING
Jeonju
Chungnam National University Sejong Hospital
RECRUITING
Sejong
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Asan Medical Center
RECRUITING
Seoul
Chung-Ang University Hospital
RECRUITING
Seoul
Ewha Woman University Seoul Hospital
RECRUITING
Seoul
Ewha Womans University Mokdong Hospital
RECRUITING
Seoul
Hallym University Kangdong Sacred Heart Hospital
RECRUITING
Seoul
Hanyang University Seoul Hospital
RECRUITING
Seoul
Konkuk University Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Kyung Hee University Medical Center
RECRUITING
Seoul
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Uijeongbu Eulji Medical Center
RECRUITING
Uijeongbu-si
Yongin Severance Hospital
RECRUITING
Yŏngin
Contact Information
Primary
Wookjin Yang, MD, PhD
ywj_2002@naver.com
+82-2-2072-2114
Backup
Seung-Hoon Lee, MD, PhD
sb0516@snu.ac.kr
+82-2-2072-1014
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2029-03
Participants
Target number of participants: 200
Treatments
Experimental: Clopidogrel-based antiplatelet therapy group
Clopidogrel 75 mg daily~Patients assigned to this group will be permitted to use additional antiplatelet drugs other than clopidogrel at the investigator's discretion.
Active_comparator: Warfarin group
Warfarin (target prothrombin time-international normalized ratio 2.0-3.0)
Sponsors
Collaborators: Samjin Pharmaceutical Co., Ltd.
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov