Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation 2

Launched by CAPITAL MEDICAL UNIVERSITY · Aug 17, 2025

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ClinConnect Summary

This clinical trial is studying the best time to start blood-thinning medicines called direct oral anticoagulants (DOACs) in people who have had a type of stroke caused by a blocked blood vessel and who also have an irregular heartbeat condition called atrial fibrillation. Specifically, it looks at patients who received emergency treatment to open the blocked vessel but then developed some bleeding in the brain. The study wants to find out if starting these blood thinners early or waiting a bit longer after the stroke is safer and more effective.

Adults aged 18 and older who have had a large stroke treated within 24 hours and have atrial fibrillation may be eligible. They must have evidence of bleeding in the brain on scans but still be well enough to participate. If you join the study, your doctors will carefully decide when to begin the blood-thinning medicine and monitor you closely to see how you do over the next three months. This trial is not yet recruiting participants, but if you or a loved one fits these criteria, it could help doctors learn how to better balance the risks and benefits of blood thinners after certain strokes.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 years or over.
• • 2. Clinical diagnosis of large vessel occlusion acute ischemic stroke.
• • 3. Emergency endovascular treatment was performed within 24 hours of stroke onset.
• 4. Atrial fibrillation (including paroxysmal, persistent or permanent atrial fibrillation), confirmed by at least one of the following:
• • 1. 12-lead ECG recording;
• • 2. Inpatient ECG telemetry;
• • 3. Prolonged ECG monitoring (e.g. Holter monitor);
• • 4. Previously established diagnosis of atrial fibrillation verified by medical records.
• 5. CT or MRI demonstrating one of the following findings:
• • 1. Parenchymatous hematoma type 1: defined as hematoma occupying less than 30% of the infarcted tissue, no substantive mass effect (Heidelberg classification);
• • 2. Parenchymatous hematoma type 2: defined as heamtoma occupying 30% or more of the infarcted tissue, with obvious mass effect (Heidelberg classification);
• • 3. Intracerebral hemorrhage outside the infarcted brain tissue or intracranial-extracerebral hemorrhage (Heidelberg classification).
• • 6. Time from stroke onset to randomization ranged from 7 days to 4 weeks.
• • 7. Written informed consent obtained from the patient or a legally authorized representative.
• Exclusion Criteria:
• • 1. Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, or myocardial infarct).
• 2. Contraindication to the use of direct oral anticoagulants (DOACs):
• • 1. Known allergy or intolerance to both factor Xa inhibitors and direct thrombin inhibitors;
• • 2. Definite indication for vitamin K antagonist (VKA) treatment (e.g. mechanical heart valve, valvular atrial fibrillation);
• • 3. Severe renal impairment (defined as creatinine exceeding 1.5 times of the upper limit of normal range) and significant hepatic dysfunction (defined as ALT or AST \> twice the upper limit of normal range) ;
• • 4. Concomitant use of medications with significant interactions with DOACs, including azole antifungals, HIV protease inhibitors, or strong CYP3A4 inducers;
• • 5. Baseline platelet count \< 100 x 109/L;
• • 6. History of coagulopathy or systemic hemorrhage.
• • 3. Prior DOAC use within 48 hours of stroke onset, or recent treatment with vitamin K antagonist (VKA) leading to INR ≥1.7 at randomization.
• • 4. Pregnant or breastfeeding women, or positive pregnancy test at admission.
• • 5. History of major surgery or severe trauma within 1 month prior to stroke onset.
• • 6. History of active bleeding within 1 month prior to stroke onset (e.g. gastrointestinal bleeding, urinary tract bleeding).
• • 7. Dual antiplatelet therapy at baseline, or strong likelihood of requiring dual antiplatelet therapy during the trial.
• • 8. Evidence of cerebral amyloid angiopathy.
• • 9. CT or MRI evidence of non-stroke pathology likely to account for the presenting clinical symptoms (e.g. mass lesion, encephalitis).
• • 10. Modified Rankin scale (mRS) score \> 1 prior to stroke onset.
• • 11. Inability to complete the 90-day follow-up.
• • 12. Currently participating in another drug clinical trial.
• • 13. Any other reason deemed by the investigator to make the patient unsuitable for participation in the trial.