NCT07609654Not yet recruitingPhase 4
Oral Anticoagulation in Patients With Prior Deep Intracerebral Hemorrhage, Atrial Fibrillation, and Ischemic Stroke
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 852 (estimated)
- First submitted
- 20 May 2026
- Start date
- 26 Oct 2026
- Primary completion date
- 1 Nov 2031
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT07609654
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 852
- From 26 Oct 2026 to the primary completion date, 1 Nov 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Requirement for continued antiplatelet therapy that cannot be replaced by oral anticoagulation.
- Previous or planned left atrial appendage occlusion.
Other illness
- 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.
Lab values
- Severe renal impairment with creatinine clearance (CrCl) \<30 mL/min.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.