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Not Yet Recruiting NCT07849777

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

Conditions: Stroke, Atrial Fibrillation (AF)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 474
Sponsor: Hao Yonggang

Location: The Fourth Affiliated Hospital of Soochow University Suzhou Jiangsu

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

Eligibility Criteria

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 \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) \

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Source: ClinicalTrials.gov (NCT07849777). StuddyBuddy aggregates publicly available trial information.