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NOT YET RECRUITING

NCT07849777

Early Anticoagulation Therapy After Endovascular Treatment for Acute Ischemic Stroke With Atrial Fibrillation

Sponsor: Hao Yonggang

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether starting a direct oral anticoagulant (DOAC) early after endovascular treatment works to improve outcomes in patients with ischemic stroke related to atrial fibrillation. It will also learn about the safety of early DOAC treatment. The main question it aims to answer is: \- Does starting DOAC treatment 24 hours after endovascular treatment improve outcomes at 3 months compared with starting it 5 days after randomization? Researchers will compare early DOAC treatment (started 24 hours after the procedure) with delayed DOAC treatment (started 5 days after randomization) to see if early treatment works better. Participants will: * Have atrial fibrillation-related acute ischemic stroke caused by a large vessel blockage in the front part of the brain, within 24 hours of symptom onset * Be randomly assigned to one of two groups after endovascular treatment: early DOAC treatment or delayed DOAC treatment * Take DOACs starting 24 hours after the procedure (early group) or 5 days after randomization (delayed group) * Be followed up for 3 months to check their recovery and any medical problems

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

474

Start Date

2026-09-30

Completion Date

2029-09-30

Last Updated

2026-09-30

Healthy Volunteers

Conditions

Stroke Atrial Fibrillation (AF)

Interventions

OTHER

Early Initiation of DOAC Therapy

Participants assigned to the intervention group will initiate DOAC therapy 24 hours after endovascular therapy (EVT). For patients receiving antiplatelet therapy before enrollment, antiplatelet agents will be discontinued upon initiation of DOAC therapy.

OTHER

Antiplatelet Bridging Followed by DOAC Therapy

DOAC therapy will be initiated 5 days after randomization. Before DOAC initiation, patients will receive bridging therapy with a single antiplatelet agent, consisting of either aspirin 100 mg once daily or clopidogrel 75 mg once daily. Dual antiplatelet therapy is not permitted. Antiplatelet therapy will be discontinued upon initiation of DOAC therapy.

Inclusion Criteria: 1. Age ≥18 years. 2. Symptom onset within 24 hours before enrollment. 3. A confirmed diagnosis of acute anterior circulation ischemic stroke. 4. A baseline NIHSS score ≥6 at admission. 5. An Alberta Stroke Program Early CT Score (ASPECTS) ≥6. 6. Computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA) confirming occlusion of the intracranial internal carotid artery (ICA) or the M1/M2 segment of the middle cerebral artery (MCA), with the patient scheduled to undergo EVT. 7. Computed tomography (CT) or magnetic resonance imaging (MRI) performed within 24 hours after EVT demonstrating no evidence of hemorrhagic transformation. 8. Documentation of paroxysmal, persistent, or permanent atrial fibrillation based on electrocardiography or previous medical records. 9. Written informed consent provided by the patient or a legally authorized representative. Exclusion Criteria: 1. Pre-stroke modified Rankin Scale (mRS) score \>2. 2. Valvular atrial fibrillation. 3. Known hypersensitivity to anticoagulants or any other contraindication to anticoagulant therapy. 4. Presence of systemic bleeding disorders, coagulopathy, or a platelet count \<100 × 10⁹/L. 5. Concomitant use of azole antifungal agents, HIV protease inhibitors, or strong CYP3A4 inducers. 6. Presence of intracranial space-occupying lesions, including intracranial tumors or cerebral vascular malformations. 7. History of major trauma or major surgery within 1 month before stroke onset. 8. Evidence of active bleeding within 1 month before stroke onset, including but not limited to gastrointestinal bleeding or genitourinary bleeding. 9. Cerebral amyloid angiopathy. 10. Severe hepatic or renal impairment, or receipt of dialysis for any cause. Severe hepatic impairment is defined as alanine aminotransferase (ALT) \>3 times the upper limit of normal (ULN) or aspartate aminotransferase (AST) \>3× ULN. Severe renal impairment is defined as serum creatinine \>3.0 mg/dL (265.2 μmol/L) or an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m². 11. Any terminal illness with an expected life expectancy of less than 6 months. 12. Breastfeeding women. 13. Participation in another interventional clinical trial within the previous 3 months. 14. Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study or interfere with study participation or completion, including but not limited to psychiatric disorders, cognitive or emotional impairment, or physical conditions that preclude adherence to study procedures or follow-up.

Locations (1)

The Fourth Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China