International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS).
S Miyakis, M D Lockshin, T Atsumi...
https://pubmed.ncbi.nlm.nih.gov/16420554Actively Recruiting
Phase 4
Age: 19Years +
All Genders
ID05995600
Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE (APS-STROKE)
Led by Seoul National University Hospital · Updated on 2024-10-16
200
Participants Needed
32
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
S
Samjin Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the best treatment for patients with antiphospholipid syndrome (APS) who have experienced an ischemic stroke. APS is linked to stroke, but the best way to prevent further strokes in these patients is unclear. Current guidelines suggest warfarin, but these are based on older studies and expert opinions rather than strong new evidence. This study aims to compare warfarin with clopidogrel-based antiplatelet therapy to find the optimal secondary prevention method for APS-related stroke. In this study, adult patients with confirmed APS and a history of ischemic stroke will be randomly assigned to one of two groups. One group will receive clopidogrel 75 mg daily and may also use other antiplatelet drugs if the doctor decides. The other group will be treated with warfarin, with a target blood clotting measure (INR) between 2.0 and 3.0. The study will follow participants for at least four years to assess outcomes. Participants will be monitored for any deaths, major cardiovascular problems, blood clots, and major bleeding events during the follow-up. The main outcome is a combined measurement of these serious events over four years. The study will provide important information to guide future treatment decisions for preventing strokes in APS patients. Throughout the study, safety and health will be closely observed by the researchers.
CONDITIONS
Brief Title
Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- History of ischemic stroke, transient ischemic attack, or retinal arterial ischemic event
- Meet laboratory diagnostic criteria for antiphospholipid syndrome (APS)
- Provide informed consent and agree to the study protocol
You will not qualify if you...
- High-risk antiphospholipid antibody profile (triple positivity or persistently high antibody levels)
- Systemic lupus erythematosus
- Unable to stop previously taken anticoagulants or antiplatelet agents
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Deemed unsuitable for participation for more than four years by investigators
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 4 years
Participants receive either clopidogrel-based antiplatelet therapy or warfarin as a secondary prevention strategy for APS-related stroke.
Trial Site Locations
Total: 32 locations
1
Hallym University Sacred Heart Hospital
Anyang, South Korea
Actively Recruiting
2
Busan Paik Hospital
Busan, South Korea
Actively Recruiting
3
Pusan National University Hospital
Busan, South Korea
Actively Recruiting
4
Chungbuk National University Hospital
Cheongju-si, South Korea
Actively Recruiting
5
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, South Korea
Actively Recruiting
6
Kangwon National University Hospital
Chuncheon, South Korea
Actively Recruiting
7
Keimyung University Dongsan Medical Center
Daegu, South Korea
Actively Recruiting
8
Yeungnam University Medical Center
Daegu, South Korea
Actively Recruiting
9
Chungnam National University Hospital
Daejeon, South Korea
Actively Recruiting
10
Hanyang University Guri Hospital
Guri-si, South Korea
Actively Recruiting
11
Chonnam National University Hospital
Gwangju, South Korea
Actively Recruiting
12
Chosun University Hospital
Gwangju, South Korea
Actively Recruiting
13
Gachon University Gil Medical Center
Incheon, South Korea
Actively Recruiting
14
Inha University Hospital
Incheon, South Korea
Actively Recruiting
15
Jeju National University Hospital
Jeju City, South Korea
Actively Recruiting
16
Jeonbuk National University Hospital
Jeonju, South Korea
Actively Recruiting
17
Chungnam National University Sejong Hospital
Sejong, South Korea
Actively Recruiting
18
Seoul National University Bundang Hospital
Seongnam, South Korea
Actively Recruiting
19
Asan Medical Center
Seoul, South Korea
Actively Recruiting
20
Chung-Ang University Hospital
Seoul, South Korea
Actively Recruiting
21
Ewha Woman University Seoul Hospital
Seoul, South Korea
Actively Recruiting
22
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Actively Recruiting
23
Hallym University Kangdong Sacred Heart Hospital
Seoul, South Korea
Actively Recruiting
24
Hanyang University Seoul Hospital
Seoul, South Korea
Actively Recruiting
25
Konkuk University Medical Center
Seoul, South Korea
Actively Recruiting
26
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
27
Kyung Hee University Medical Center
Seoul, South Korea
Actively Recruiting
28
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, South Korea
Actively Recruiting
29
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
30
Severance Hospital
Seoul, South Korea
Actively Recruiting
31
Uijeongbu Eulji Medical Center
Uijeongbu-si, South Korea
Actively Recruiting
32
Yongin Severance Hospital
Yongin, South Korea
Actively Recruiting
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Research Team
W
Wookjin Yang, MD, PhD
S
Seung-Hoon Lee, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Antiphospholipid syndrome in northwest Italy (APS Piedmont Cohort): demographic features, risk factors, clinical and laboratory profile.
M T Bertero, M Bazzan, R Carignola...
https://pubmed.ncbi.nlm.nih.gov/22635240Current status and role of antiphospholipid antibody testing in cryptogenic stroke.
Wookjin Yang, Min Kyoung Kang, Sue Young Ha...
https://pubmed.ncbi.nlm.nih.gov/3480031416th International Congress on Antiphospholipid Antibodies Task Force Report on Antiphospholipid Syndrome Treatment Trends.
Hannah Cohen, Maria J Cuadrado, Doruk Erkan...
https://pubmed.ncbi.nlm.nih.gov/33100166EULAR recommendations for the management of antiphospholipid syndrome in adults.
Maria G Tektonidou, Laura Andreoli, Marteen Limper...
https://pubmed.ncbi.nlm.nih.gov/31092409Guidelines on the investigation and management of antiphospholipid syndrome.
David Keeling, Ian Mackie, Gary W Moore...
https://pubmed.ncbi.nlm.nih.gov/22313321Antiphospholipid thrombosis: clinical course after the first thrombotic event in 70 patients.
M H Rosove, P M Brewer
https://pubmed.ncbi.nlm.nih.gov/1637025The management of thrombosis in the antiphospholipid-antibody syndrome.
M A Khamashta, M J Cuadrado, F Mujic...
https://pubmed.ncbi.nlm.nih.gov/7885428A retrospective review of 61 patients with antiphospholipid syndrome. Analysis of factors influencing recurrent thrombosis.
S Krnic-Barrie, C R O'Connor, S W Looney...
https://pubmed.ncbi.nlm.nih.gov/93826672021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association.
Dawn O Kleindorfer, Amytis Towfighi, Seemant Chaturvedi...
https://pubmed.ncbi.nlm.nih.gov/34024117