Intracerebral HemorrhagePhase 4OASIS-AFNCT07609654
Oral Anticoagulation in Patients With Prior Deep Intracerebral Hemorrhage, Atrial Fibrillation, and Ischemic Stroke
A Phase 4 study testing Apixaban and No Oral Anticoagulation Strategy in people with Intracerebral Hemorrhage and Atrial Fibrillation (AF), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Atrial Fibrillation (AF), Ischemia Stroke
- What is being tested?
- Apixaban and No Oral Anticoagulation Strategy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2026to 1 Feb 2032
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Modified Rankin Scale (mRS) score >3.
- MRI evidence of cortical superficial siderosis (cSS) or severe lobar cerebral microbleeds.
- Severe uncontrolled hypertension refractory to medical therapy.
- Severe renal impairment with creatinine clearance (CrCl) <30 mL/min.
- Requirement for continuous oral anticoagulation for an indication other than atrial fibrillation, such as a mechanical heart valve or venous thromboembolism.
- Requirement for continued antiplatelet therapy that cannot be replaced by oral anticoagulation.
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- 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.
- Previous or planned left atrial appendage occlusion.
- Pregnancy, breastfeeding, or planned pregnancy during the study period.
- Inability to comply with study procedures or an expected life expectancy <6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhengjiang, 310009
Min Lou, PhD, +8657187784810, lm99@zju.edu.cn
About this study
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
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.
- Being tested
- Apixaban, No Oral Anticoagulation Strategy
- Keywords
- Deep Intracerebral Hemorrhage, Non-lobar Intracerebral Hemorrhage, Atrial Fibrillation, Ischemic Stroke, Apixaban, Oral Anticoagulation
- Medical subject headings
- Cerebral Hemorrhage, Atrial Fibrillation, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Oral apixaban 5 mg twice daily, with dose reduction according to the approved prescribing information when indicated.
No Oral Anticoagulation StrategyOther
No oral anticoagulation; single antiplatelet therapy or no antithrombotic therapy is permitted at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | Participants assigned to the anticoagulation group will receive oral apixaban 5 mg twice daily. Dose reduction will be performed according to the approved prescribing information when indicated. Receives: Drug: Apixaban |
| Non-Anticoagulation Therapy | Active comparator | Participants will not receive oral anticoagulation. Single antiplatelet therapy, such as aspirin or clopidogrel, or no antithrombotic therapy is permitted at the discretion of the treating physician according to clinical guidelines and individual patient characteristics. Receives: Other: No Oral Anticoagulation Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Occurrence of Recurrent Ischemic Stroke or Recurrent Intracerebral Hemorrhage
Time from randomization to the first occurrence of recurrent ischemic stroke or recurrent intracerebral hemorrhage, whichever occurs first.
Measured: From randomization to the first qualifying event or the end of follow-up, up to 36 months
Secondary outcomes (6)
First Recurrent Ischemic Stroke
Occurrence of the first recurrent ischemic stroke during follow-up.
Measured: Up to 36 months
First Recurrent Intracerebral Hemorrhage
Occurrence of the first recurrent intracerebral hemorrhage during follow-up.
Measured: Up to 36 months
Vascular Death
Death due to a vascular cause during follow-up.
Measured: Up to 36 months
All-Cause Death
Death from any cause during follow-up.
Measured: Up to 36 months
Major Bleeding Events
Major bleeding events defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria.
Measured: Up to 36 months
Modified Rankin Scale (mRS) Score Distribution
Distribution of scores on the modified Rankin Scale, ranging from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.
Measured: 6, 12, 24, and 36 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start26 Oct 2026 (estimated)
- Primary completion1 Nov 2031 (estimated)
- Study completion1 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 852 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Lou, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Min Lou, PhD, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609654
- Sponsor's protocol ID
- OASIS-AF
- Acronym
- OASIS-AF
- Status last verified
- Oct 2026
- First submitted
- 20 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No