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MinorEnrollment closed, study ongoingPrimary and study completion pushed from Mar 2029 to Jun 2029 · Site details revised at 32 of 32 sitesv7Show 2 more changesShow less
Primary and study completion pushed from Mar 2029 to Jun 2029
Site details revised at 32 of 32 sites
NotableEnrollment target: 400 to 200Primary completion date: Jul 2027 to Mar 2029 · Completion date: Oct 2028 to Mar 2029 · Eligibility criteria revised · 1 morev6Show 4 more changesShow less
Primary completion date: Jul 2027 to Mar 2029
Completion date: Oct 2028 to Mar 2029
Eligibility criteria revised
Secondary endpoints: details revised at 8 of 8 entries
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 35 to 32 · Primary completion date: May 2027 to Jul 2027 · Completion date: Aug 2028 to Oct 2028 · 1 morev4Show 4 more changesShow less
Study sites: 35 to 32
Primary completion date: May 2027 to Jul 2027
Completion date: Aug 2028 to Oct 2028
Start date changed from estimate of Dec 2023 to Feb 20, 2024
NotableStart date: Sep 2023 to Dec 2023Primary completion date: Feb 2027 to May 2027 · Completion date: May 2028 to Aug 2028v3Show 2 more changesShow less
Primary completion date: Feb 2027 to May 2027
Completion date: May 2028 to Aug 2028
MinorStart date: Aug 2023 to Sep 2023v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.