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

October 13, 2024 updated by: Seung-Hoon Lee, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Seung-Hoon Lee, MD, PhD
  • Phone Number: +82-2-2072-1014
  • Email: sb0516@snu.ac.kr

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of
        • Recruiting
        • Hallym University Sacred Heart Hospital
      • Busan, Korea, Republic of
        • Recruiting
        • Pusan National University Hospital
      • Busan, Korea, Republic of
        • Recruiting
        • Busan Paik Hospital
      • Cheongju-si, Korea, Republic of
        • Recruiting
        • Chungbuk National University Hospital
      • Chuncheon, Korea, Republic of
        • Recruiting
        • Kangwon National University Hospital
      • Chuncheon, Korea, Republic of
        • Recruiting
        • Hallym University Chuncheon Sacred Heart Hospital
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of
        • Recruiting
        • Yeungnam University Medical Center
      • Daejeon, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
      • Guri-si, Korea, Republic of
        • Recruiting
        • Hanyang University Guri Hospital
      • Gwangju, Korea, Republic of
        • Recruiting
        • Chonnam National University Hospital
      • Gwangju, Korea, Republic of
        • Recruiting
        • Chosun University Hospital
      • Incheon, Korea, Republic of
        • Recruiting
        • Inha University Hospital
      • Incheon, Korea, Republic of
        • Recruiting
        • Gachon University Gil Medical Center
      • Jeju, Korea, Republic of
        • Recruiting
        • Jeju National University Hospital
      • Jeonju, Korea, Republic of
        • Recruiting
        • Jeonbuk National University Hospital
      • Sejong, Korea, Republic of
        • Recruiting
        • Chungnam National University Sejong Hospital
      • Seongnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Hallym University Kangdong Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Hanyang University Seoul Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Kyung Hee University Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Ewha Woman University Seoul Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Metropolitan Government-Seoul National University Boramae Medical Center
      • Uijeongbu, Korea, Republic of
        • Recruiting
        • Uijeongbu Eulji Medical Center
      • Yongin, Korea, Republic of
        • Recruiting
        • Yongin Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 four years, as per the investigators' discretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Antiplatelet Drug
Clopidogrel ± other antiplatelet drug
Active Comparator: Warfarin group
Warfarin (target prothrombin time-international normalized ratio 2.0-3.0)
Drug: Warfarin
Warfarin (target prothrombin time-international normalized ratio 2.0-3.0)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint
Time Frame: 4 years
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.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 4 years
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.
4 years
Ischemic stroke
Time Frame: 4 years
Ischemic stroke or transient ischemic attack
4 years
Any bleeding
Time Frame: 4 years
Major or minor bleeding according to definitions from BARC
4 years
Major bleeding
Time Frame: 4 years
BARC bleeding type 3 or 5
4 years
Intracranial bleeding
Time Frame: 4 years
Intracranial bleeding that is objectively confirmed by brain imaging
4 years
Clinically relevant non-major bleeding
Time Frame: 4 years

Any bleeding that does not fit the criteria for major bleeding but does meet at least one of the following criteria:

  1. requiring nonsurgical, medical intervention by a healthcare professional
  2. leading to hospitalization or increased level of care
  3. prompting evaluation.
4 years
Any death
Time Frame: 4 years
Death from any cause
4 years
Thrombosis-related death
Time Frame: 4 years
Death from arterial, venous, or capillary thrombotic events
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Samjin Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Seung-Hoon Lee, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 13, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2304-096-1425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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