Back to resultsComparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin as Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE (APS-STROKE)
Primary Purpose
Antiphospholipid Syndrome, Ischemic Stroke, Transient Ischemic Attack
Status
Not yet recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Antiplatelet Drug
Warfarin
Sponsored by
About this trial
This is an interventional prevention trial for Antiphospholipid Syndrome focused on measuring Antiphospholipid syndrome, Ischemic stroke, Secondary prevention, Thrombosis
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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 two years, as per the investigators' discretion
Sites / Locations
- Hallym University Sacred Heart Hospital
- Busan Paik Hospital
- Pusan National University Hospital
- Chungbuk National University Hospital
- Hallym University Chuncheon Sacred Heart Hospital
- Kangwon National University Hospital
- Keimyung University Dongsan Medical Center
- Yeungnam University Medical Center
- Chungnam National University Hospital
- Myongji Hospital
- National Health Insurance Service Ilsan Hospital
- Hanyang University Guri Hospital
- Chonnam National University Hospital
- Chosun University Hospital
- Chung-Ang University Gwangmyeong Hospital
- Gachon University Gil Medical Center
- Inha University Hospital
- Jeju National University Hospital
- Jeonbuk National University Hospital
- Chungnam National University Sejong Hospital
- Seoul National University Bundang Hospital
- Asan Medical Center
- Chung-Ang University Hospital
- Ewha Woman University Seoul Hospital
- Ewha Womans University Mokdong Hospital
- Hallym University Kangdong Sacred Heart Hospital
- Hanyang University Seoul Hospital
- Konkuk University Medical Center
- Korea University Anam Hospital
- Kyung Hee University Medical Center
- Seoul Metropolitan Government-Seoul National University Boramae Medical Center
- Seoul National University Hospital
- Severance Hospital
- Uijeongbu Eulji Medical Center
- Yongin Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clopidogrel-based antiplatelet therapy group
Warfarin group
Arm Description
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.
Warfarin (target prothrombin time-international normalized ratio 2.0-3.0)
Outcomes
Primary Outcome Measures
Composite endpoint
Composite endpoint of any death, major adverse cardiovascular events (MACEs), systemic thromboembolic events, and major bleeding. MACE includes any stroke, transient ischemic attack, and acute coronary syndrome (i.e., ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and hospitalization with unstable angina) in this study. Major bleeding refers to bleeding events meeting the criteria for Bleeding Academic Research Consortium (BARC) type 3 or 5.
Secondary Outcome Measures
MACE
MACE includes any stroke, transient ischemic attack, and acute coronary syndrome (i.e., ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and hospitalization with unstable angina) in this study.
Ischemic stroke
Ischemic stroke or transient ischemic attack
Any bleeding
Major or minor bleeding according to definitions from BARC
Major bleeding
BARC bleeding type 3 or 5
Intracranial bleeding
Intracranial bleeding that is objectively confirmed by brain imaging
Clinically relevant non-major bleeding
Any bleeding that does not fit the criteria for major bleeding but does meet at least one of the following criteria:
requiring nonsurgical, medical intervention by a healthcare professional
leading to hospitalization or increased level of care
prompting evaluation.
Any death
Death from any cause
Thrombosis-related death
Death from arterial, venous, or capillary thrombotic events
Full Information
NCT ID
NCT05995600
First Posted
August 9, 2023
Last Updated
August 15, 2023
Sponsor
Seoul National University Hospital
Collaborators
Samjin Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05995600
Brief Title
Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin as Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE
Acronym
APS-STROKE
Official Title
Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin as Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE (APS-STROKE)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
May 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Samjin Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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 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 2 years. This study would provide valuable information for determining the optimal secondary prevention strategy for APS-related stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antiphospholipid Syndrome, Ischemic Stroke, Transient Ischemic Attack, Cerebrovascular Disease, Cardiovascular Diseases, Major Bleed
Keywords
Antiphospholipid syndrome, Ischemic stroke, Secondary prevention, Thrombosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) trial
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clopidogrel-based antiplatelet therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Warfarin group
Arm Type
Active Comparator
Arm Description
Warfarin (target prothrombin time-international normalized ratio 2.0-3.0)
Intervention Type
Drug
Intervention Name(s)
Antiplatelet Drug
Intervention Description
Clopidogrel ± other antiplatelet drug
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
Warfarin (target prothrombin time-international normalized ratio 2.0-3.0)
Primary Outcome Measure Information:
Title
Composite endpoint
Description
Composite endpoint of any death, major adverse cardiovascular events (MACEs), systemic thromboembolic events, and major bleeding. MACE includes any stroke, transient ischemic attack, and acute coronary syndrome (i.e., ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and hospitalization with unstable angina) in this study. Major bleeding refers to bleeding events meeting the criteria for Bleeding Academic Research Consortium (BARC) type 3 or 5.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
MACE
Description
MACE includes any stroke, transient ischemic attack, and acute coronary syndrome (i.e., ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and hospitalization with unstable angina) in this study.
Time Frame
2 years
Title
Ischemic stroke
Description
Ischemic stroke or transient ischemic attack
Time Frame
2 years
Title
Any bleeding
Description
Major or minor bleeding according to definitions from BARC
Time Frame
2 years
Title
Major bleeding
Description
BARC bleeding type 3 or 5
Time Frame
2 years
Title
Intracranial bleeding
Description
Intracranial bleeding that is objectively confirmed by brain imaging
Time Frame
2 years
Title
Clinically relevant non-major bleeding
Description
Any bleeding that does not fit the criteria for major bleeding but does meet at least one of the following criteria:
requiring nonsurgical, medical intervention by a healthcare professional
leading to hospitalization or increased level of care
prompting evaluation.
Time Frame
2 years
Title
Any death
Description
Death from any cause
Time Frame
2 years
Title
Thrombosis-related death
Description
Death from arterial, venous, or capillary thrombotic events
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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 two years, as per the investigators' discretion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wookjin Yang, MD
Phone
+82-2-2072-2114
Email
ywj_2002@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Hoon Lee, MD, PhD
Phone
+82-2-2072-1014
Email
sb0516@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Hoon Lee, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
Facility Name
Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
Country
Korea, Republic of
Facility Name
Hallym University Chuncheon Sacred Heart Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Kangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Myongji Hospital
City
Goyang
Country
Korea, Republic of
Facility Name
National Health Insurance Service Ilsan Hospital
City
Goyang
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri-si
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Chosun University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Chung-Ang University Gwangmyeong Hospital
City
Gwangmyeong
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju
Country
Korea, Republic of
Facility Name
Jeonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Chungnam National University Sejong Hospital
City
Sejong
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Woman University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University Kangdong Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Uijeongbu Eulji Medical Center
City
Uijeongbu
Country
Korea, Republic of
Facility Name
Yongin Severance Hospital
City
Yongin
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin as Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE
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