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NCT Number: NCT07609654

Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF

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.

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Key information

Conditions

Acute Ischemic Stroke Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (AF) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Heart Diseases Hemorrhage Intracerebral Hemorrhage Intracranial Hemorrhages Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Direct Oral Anticoagulants (DOACs)

Drug

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

Antiplatelet Therapy or No Antithrombotic Therapy

Drug

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

Primary outcomes

  1. Incidence of the Composite Endpoint of Recurrent Stroke

    Time frame: Up to 12 months

    Proportion of participants experiencing a recurrent ischemic stroke or a recurrent intracerebral hemorrhage (ICH). Events will be adjudicated by independent, blinded clinical assessors.

Secondary outcomes

  1. Incidence of Recurrent Ischemic Stroke

    Time frame: Up to 12 months.

    Proportion of participants experiencing a recurrent acute ischemic stroke.

  2. Incidence of Recurrent Intracerebral Hemorrhage (ICH)

    Time frame: Up to 12 months.

    Proportion of participants experiencing a recurrent spontaneous ICH.

  3. Time to First Occurrence of Recurrent Ischemic Stroke

    Time frame: Up to 12 months

    Time interval from randomization to the confirmed diagnosis of a recurrent ischemic stroke.

  4. Time to First Occurrence of Recurrent Intracerebral Hemorrhage (ICH)

    Time frame: Up to 12 months

    Time interval from randomization to the confirmed diagnosis of a recurrent ICH.

  5. Incidence of Vascular Death

    Time frame: Up to 12 months

    Proportion of participants who die from vascular causes (e.g., fatal stroke, fatal myocardial infarction).

  6. All-Cause Mortality Rate

    Time frame: Up to 12 months

    Proportion of participants who die from any cause during the follow-up period.

  7. Incidence of Major Bleeding Events

    Time frame: Up to 12 months

    Proportion of participants experiencing a major bleeding event, defined strictly according to the International Society on Thrombosis and Haemostasis (ISTH) criteria.

  8. Incidence of Clinically Relevant Non-Major (CRNM) Bleeding

    Time frame: Up to 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Lou, PhD, MD

CONTACT

[email protected]

8613958007213

Wansi Zhong, MD

CONTACT

[email protected]

8618757155806

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Acronym: OASIS-AF

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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