Status:
RECRUITING
Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation
Lead Sponsor:
Capital Medical University
Conditions:
Ischemic Stroke
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study evaluates the safety and efficacy of early versus delayed initiation of direct oral anticoagulants (DOACs) in patients with acute ischemic stroke related to atrial fibrillation after emerge...
Detailed Description
This is a multicenter, prospective, open-label, randomized controlled trial evaluating the safety and efficacy of different initiation timings of direct oral anticoagulants (DOACs) therapy in patients...
Eligibility Criteria
Inclusion
- Aged 18 years or over.
- Clinical diagnosis of large vessel occlusion acute ischemic stroke.
- Emergency endovascular treatment was performed within 24 hours of stroke onset.
- Atrial fibrillation (including paroxysmal, persistent or permanent atrial fibrillation), confirmed by at least one of the following:
- 12-lead ECG recording
- Inpatient ECG telemetry
- Prolonged ECG monitoring (e.g. Holter monitor)
- Previously established diagnosis of atrial fibrillation verified by medical records.
- CT or MRI demonstrating one of the following findings:
- No hemorrhagic transformation;
- Hemorrhagic infarction type 1 (HI1), defined as small petechiae along the margins of the infarct (Heidelberg classification);
- Hemorrhagic infarction type 2 (HI2), defined as confluent petechiae within the infarcted area without space-occupying effect (Heidelberg classification).
- Time from stroke onset to randomization was within 72 hours.
- Written informed consent obtained from the patient or a legally authorized representative.
Exclusion
- Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, or myocardial infarct).
- Contraindication to the use of direct oral anticoagulants (DOACs):
- Known allergy or intolerance to both factor Xa inhibitors and direct thrombin inhibitors;
- Definite indication for vitamin K antagonist (VKA) treatment (e.g. mechanical heart valve, valvular atrial fibrillation);
- 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) ;
- Concomitant use of medications with significant interactions with DOACs, including azole antifungals, HIV protease inhibitors, or strong CYP3A4 inducers;
- Baseline platelet count \< 100 x 109/L;
- History of coagulopathy or systemic hemorrhage.
- Prior DOAC use within 48 hours of stroke onset, or recent treatment with vitamin K antagonist (VKA) leading to INR ≥1.7 at randomization.
- Pregnant or breastfeeding women, or positive pregnancy test at admission.
- History of major surgery or severe trauma within 1 month prior to stroke onset.
- History of active bleeding within 1 month prior to stroke onset (e.g. gastrointestinal bleeding, urinary tract bleeding).
- Dual antiplatelet therapy at baseline, or strong likelihood of requiring dual antiplatelet therapy during the trial.
- Evidence of cerebral amyloid angiopathy.
- CT or MRI evidence of non-stroke pathology likely to account for the presenting clinical symptoms (e.g. mass lesion, encephalitis).
- Modified Rankin scale (mRS) score \> 1 prior to stroke onset.
- Inability to complete the 90-day follow-up.
- Currently participating in another drug clinical trial.
- Any other reason deemed by the investigator to make the patient unsuitable for participation in the trial.
Key Trial Info
Start Date :
September 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
438 Patients enrolled
Trial Details
Trial ID
NCT07139301
Start Date
September 4 2025
End Date
August 31 2026
Last Update
September 8 2025
Active Locations (9)
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1
Xuanwu Hospital, Beijing, Beijing 100053
Beijing, China
2
Guoluo Prefecture People's Hospital
Guoluo, China
3
Huanghua Municipal People's Hospital
Huanghua, China
4
First Affiliated Hospital of Henan Polytechnic University
Jiaozuo, China