Apixaban or no blood thinner for atrial fibrillation after deep brain bleeding
Tests apixaban against no blood thinner in adults with atrial fibrillation and prior stroke.
Plain-language title generated from the registry record
Registry title: Oral Anticoagulation in Patients With Prior Deep Intracerebral Hemorrhage, Atrial Fibrillation, and Ischemic Stroke
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 4
Where in China
- Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of MedicineHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07609654
- Record updated
- 20 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age ≥18 years; Ischemic stroke; History of spontaneous, non-traumatic deep intracerebral hemorrhage confirmed by CT or MRI, located in the basal ganglia, thalamus, pons, or deep cerebellum, with no lobar cortical involvement and no intraventricular hemorrhage; Non-valvular atrial fibrillation, including paroxysmal, persistent, or permanent atrial fibrillation; Written informed consent provided by the participant or a legally authorized representative.
Exclusion: Requirement for continued antiplatelet therapy that cannot be replaced by oral anticoagulation; Previous or planned left atrial appendage occlusion; Severe uncontrolled hypertension refractory to medical therapy; Requirement for continuous oral anticoagulation for an indication other than atrial fibrillation, such as a mechanical heart valve or venous thromboembolism; Contraindication to apixaban according to the approved prescribing information, other than the history of spontaneous intracerebral hemorrhage, including hypersensitivity, active bleeding, other high-risk bleeding lesions, or hepatic disease associated with coagulopathy and clinically relevant bleeding risk; Severe renal impairment with creatinine clearance (CrCl) <30 mL/min; Modified Rankin Scale (mRS) score >3; MRI evidence of cortical superficial siderosis (cSS) or severe lobar cerebral microbleeds; Pregnancy, breastfeeding, or planned pregnancy during the study period; Inability to comply with study procedures or an expected life expectancy <6 months.