Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF (OASIS-AF)

A Prospective, Multicenter, Randomized Controlled Trial of Anticoagulation Therapy After Ischemic Stroke in Patients With Previous Intracerebral Hemorrhage and Atrial Fibrillation

This prospective, multicenter, randomized controlled trial aims to evaluate the efficacy and safety of initiating direct oral anticoagulants (DOACs) in patients with a history of spontaneous intracerebral hemorrhage (ICH) and non-valvular atrial fibrillation (AF) who have recently suffered an acute ischemic stroke. Existing evidence regarding the optimal antithrombotic strategy for this specific high-risk "double-jeopardy" population remains largely undefined. Eligible participants will be randomized in a 1:1 ratio to either receive oral anticoagulation therapy or a non-anticoagulation standard of care. The primary objective is to assess the incidence of a composite endpoint consisting of recurrent ischemic stroke and recurrent ICH over a 12-month follow-up period.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke; Intracerebral Hemorrhage; Atrial Fibrillation (AF)
• Intervention / Treatment: Drug: Direct Oral Anticoagulants (DOACs); Drug: Antiplatelet Therapy or No Antithrombotic Therapy

• Study Type: Interventional
• Enrollment (Estimated): 852
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Min Lou, PhD, MD; Phone Number: 8613958007213; Email: lm99@zju.edu.cn
• Study Contact Backup: Name: Wansi Zhong, MD; Phone Number: 8618757155806; Email: 21718233@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. Diagnosis of acute ischemic stroke, with no evidence of hemorrhagic transformation confirmed by acute neuroimaging (MRI and CT).
3. Documented history of spontaneous intracerebral hemorrhage (ICH).
4. Confirmed non-valvular atrial fibrillation (including paroxysmal, persistent, or permanent subtypes).
5. Provision of written informed consent by the patient or a legally authorized representative.

Exclusion Criteria:

1. Severe baseline disability, defined as a pre-stroke Modified Rankin Scale (mRS) score > 4.
2. Intracerebral hemorrhage definitively caused by underlying structural vascular lesions (e.g., AVM, aneurysm) or systemic diseases.
3. Severe, uncontrolled hypertension refractory to medical therapy.
4. Severe renal impairment, defined as an estimated Creatinine Clearance (CrCl) < 30 mL/min.
5. Clinical indications necessitating continuous oral anticoagulation therapy other than atrial fibrillation (e.g., mechanical prosthetic heart valves, deep vein thrombosis, pulmonary embolism).
6. Documented contraindications to direct oral anticoagulants according to the product summary of characteristics (excluding the previous spontaneous ICH), including but not limited to hypersensitivity, active clinically significant bleeding, high-risk bleeding lesions, or hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
7. Prior deployment of, or planned procedure for, a left atrial appendage occlusion (LAAO) device.
8. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
9. Estimated life expectancy of less than 1 year due to concomitant terminal illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anticoagulation Therapy; Participants in this arm will receive early initiation of direct oral anticoagulants (DOACs) following an individualized clinical assessment. Initiation is contingent upon the exclusion of hemorrhagic transformation via head CT/SWI within 24 hours prior to treatment.	Drug: Direct Oral Anticoagulants (DOACs); Administration of approved DOACs (e.g., apixaban, rivaroxaban, edoxaban, or dabigatran) at standard stroke prevention dosages.
Active Comparator: Non-Anticoagulation Therapy; Participants will not receive oral anticoagulation therapy during the study period. Patients may be prescribed single antiplatelet therapy (e.g., aspirin or clopidogrel) or no antithrombotic therapy, strictly at the discretion of the treating physician based on current clinical guidelines and individual patient risk profiles.	Drug: Antiplatelet Therapy or No Antithrombotic Therapy; Administration of single antiplatelet agents or avoidance of antithrombotic therapy, representing the current variable standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the Composite Endpoint of Recurrent Stroke	Proportion of participants experiencing a recurrent ischemic stroke or a recurrent intracerebral hemorrhage (ICH). Events will be adjudicated by independent, blinded clinical assessors.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Recurrent Ischemic Stroke	Proportion of participants experiencing a recurrent acute ischemic stroke.	Up to 12 months.
Incidence of Recurrent Intracerebral Hemorrhage (ICH)	Proportion of participants experiencing a recurrent spontaneous ICH.	Up to 12 months.
Time to First Occurrence of Recurrent Ischemic Stroke	Time interval from randomization to the confirmed diagnosis of a recurrent ischemic stroke.	Up to 12 months
Time to First Occurrence of Recurrent Intracerebral Hemorrhage (ICH)	Time interval from randomization to the confirmed diagnosis of a recurrent ICH.	Up to 12 months
Incidence of Vascular Death	Proportion of participants who die from vascular causes (e.g., fatal stroke, fatal myocardial infarction).	Up to 12 months
All-Cause Mortality Rate	Proportion of participants who die from any cause during the follow-up period.	Up to 12 months
Incidence of Major Bleeding Events	Proportion of participants experiencing a major bleeding event, defined strictly according to the International Society on Thrombosis and Haemostasis (ISTH) criteria.	Up to 12 months
Incidence of Clinically Relevant Non-Major (CRNM) Bleeding	Proportion of participants experiencing bleeding events that do not meet the ISTH criteria for major bleeding but result in medical intervention, hospitalization, or discontinuation of the study drug.	Up to 12 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Min Lou, PhD, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Anticoagulation; Intracerebral Hemorrhage; Atrial Fibrillation (AF); Acute Ischemic Stroke; DOACs
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Hemorrhage; Intracranial Hemorrhages; Stroke; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Atrial Fibrillation; Cerebral Hemorrhage; N(4)-oleylcytosine arabinoside
• Other Study ID Numbers: OASIS-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No