Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF

NCT07609654 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: OASIS-AF
• Study Type: interventional
• Target: 852
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Ischemic Stroke; Intracerebral Hemorrhage; Atrial Fibrillation (AF)

Keywords

Acute Ischemic Stroke; Intracerebral Hemorrhage; Atrial Fibrillation (AF); DOACs; Anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence of Recurrent Ischemic Stroke

  Up to 12 months.

• Incidence of Recurrent Intracerebral Hemorrhage (ICH)

  Up to 12 months.

• Time to First Occurrence of Recurrent Ischemic Stroke

  Up to 12 months

• Time to First Occurrence of Recurrent Intracerebral Hemorrhage (ICH)

  Up to 12 months

• Incidence of Vascular Death

  Up to 12 months

Study Arms (2)

Anticoagulation Therapy

EXPERIMENTAL

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)

Non-Anticoagulation Therapy

ACTIVE COMPARATOR

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

Interventions

Direct Oral Anticoagulants (DOACs) DRUG

Administration of approved DOACs (e.g., apixaban, rivaroxaban, edoxaban, or dabigatran) at standard stroke prevention dosages.

Anticoagulation Therapy

Antiplatelet Therapy or No Antithrombotic Therapy DRUG

Administration of single antiplatelet agents or avoidance of antithrombotic therapy, representing the current variable standard of care.

Non-Anticoagulation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe baseline disability, defined as a pre-stroke Modified Rankin Scale (mRS) score \> 4.
• Intracerebral hemorrhage definitively caused by underlying structural vascular lesions (e.g., AVM, aneurysm) or systemic diseases.
• Severe, uncontrolled hypertension refractory to medical therapy.
• Severe renal impairment, defined as an estimated Creatinine Clearance (CrCl) \< 30 mL/min.
• Clinical indications necessitating continuous oral anticoagulation therapy other than atrial fibrillation (e.g., mechanical prosthetic heart valves, deep vein thrombosis, pulmonary embolism).
• 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.
• Prior deployment of, or planned procedure for, a left atrial appendage occlusion (LAAO) device.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
• Estimated life expectancy of less than 1 year due to concomitant terminal illness.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage; Atrial Fibrillation

Interventions

N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases

Study Officials

• Min Lou, PhD, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Lou, PhD, MD

CONTACT

8613958007213; lm99@zju.edu.cn

Wansi Zhong, MD

CONTACT

8618757155806; 21718233@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share