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NOT YET RECRUITING
NCT07609654
PHASE4

Oral Anticoagulation in Patients With Prior Deep Intracerebral Hemorrhage, Atrial Fibrillation, and Ischemic Stroke

Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine

View on ClinicalTrials.gov

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

DRUG

Apixaban

Oral apixaban 5 mg twice daily, with dose reduction according to the approved prescribing information when indicated.

OTHER

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