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Oral Anticoagulation in Patients With Prior Deep Intracerebral Hemorrhage, Atrial Fibrillation, and Ischemic Stroke
Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
Summary
This prospective, multicenter, randomized, open-label, blinded-endpoint trial aims to evaluate the efficacy and safety of oral anticoagulation with apixaban in patients with non-valvular atrial fibrillation, ischemic stroke, and a history of spontaneous, non-traumatic deep intracerebral hemorrhage. Eligible intracerebral hemorrhage is located in the basal ganglia, thalamus, pons, or deep cerebellum and is non-lobar and non-intraventricular. Participants will be randomized in a 1:1 ratio to apixaban or a no-oral-anticoagulation strategy. Participants assigned to apixaban will receive 5 mg twice daily, with dose reduction according to the approved prescribing information when indicated. Participants assigned to no oral anticoagulation may receive single antiplatelet therapy or no antithrombotic therapy at the discretion of the treating physician. Participants will be followed for at least 6 months and up to 36 months. The primary outcome is the first occurrence of recurrent ischemic stroke or recurrent intracerebral hemorrhage, whichever occurs first.
Official title: A Prospective, Multicenter, Randomized, Open-Label, Blinded-Endpoint Trial of Apixaban Versus No Oral Anticoagulation in Patients With Prior Deep Intracerebral Hemorrhage, Atrial Fibrillation, and Ischemic Stroke
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
852
Start Date
2026-10-26
Completion Date
2032-02-01
Last Updated
2026-10-20
Healthy Volunteers
No
Interventions
Apixaban
Oral apixaban 5 mg twice daily, with dose reduction according to the approved prescribing information when indicated.
No Oral Anticoagulation Strategy
No oral anticoagulation; single antiplatelet therapy or no antithrombotic therapy is permitted at the discretion of the treating physician.
Locations (1)
Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhengjiang, China