Clinical Trial

Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF

Study acronym: OASIS-AF
Not Yet Recruiting Phase 4
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Summary
This prospective, multicenter, randomized controlled trial aims to evaluate the efficacy and safety of initiating direct oral anticoagulants (DOACs) in patients with a history of spontaneous intracerebral hemorrhage (ICH) and non-valvular atrial fibrillation (AF) who have recently suffered an acute ischemic stroke. Existing evidence regarding the optimal antithrombotic strategy for this specific high-risk "double-jeopardy" population remains largely undefined. Eligible participants will be randomized in a 1:1 ratio to either receive oral anticoagulation therapy or a non-anticoagulation standard of care. The primary objective is to assess the incidence of a composite endpoint consisting of recurrent ischemic stroke and recurrent ICH over a 12-month follow-up period.
Protocol Amendment History 1 change
notable Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University -> Second Affiliated Hospital, Zhejiang University, School of Medicine 2026-08-09
Trial Details
NCT Number NCT07609654
Lead Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions Acute Ischemic Stroke, Intracerebral Hemorrhage, Atrial Fibrillation (AF)
Enrollment 852 participants
Start Date 2026-06-01
Primary Completion 2029-06-01 (estimated)
Study Completion 2029-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-27