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Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF

Study acronym: OASIS-AF
StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Changed Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University to Second Affiliated Hospital, Zhejiang University, School of Medicine
  2. Study 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT07609654
Lead Sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine
Conditions
(from sponsor)		 Acute Ischemic Stroke, Intracerebral Hemorrhage, Atrial Fibrillation (AF)
Related terms Atrial Fibrillation, Cerebral Hemorrhage, Ischemic Stroke
Enrollment 852 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov