When to start anticoagulants after emergency clot-removal for stroke with atrial fibrillation

Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation：a Randomised Controlled Trial

This trial tests whether starting direct oral anticoagulants early or waiting a bit is safer and more effective for adults with atrial fibrillation who had emergency clot-removal for an ischemic stroke.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 438 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capital Medical University (other)
• Locations: 40 sites (Ma’anshan, Anhui and 39 other locations)
• Trial ID: NCT07139301 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective, open-label randomized trial that assigns adults with atrial fibrillation and large-vessel ischemic stroke who underwent emergency endovascular therapy to early versus delayed initiation of direct oral anticoagulants (DOACs). Enrollment occurs within 72 hours of stroke onset and EVT must have been performed within 24 hours. Imaging must show either no hemorrhagic transformation or only minor hemorrhagic infarction (HI1 or HI2) per the Heidelberg classification. The study compares safety outcomes such as intracranial hemorrhage and recurrent ischemic events and measures functional recovery after treatment initiation.

Who should consider this trial

Good fit: Adults (≥18) with large-vessel occlusion ischemic stroke related to atrial fibrillation who received emergency endovascular therapy within 24 hours and meet imaging criteria (no hemorrhage or HI1/HI2) and can be randomized within 72 hours are ideal candidates.

Not a fit: Patients with major hemorrhagic transformation, high baseline bleeding risk, non‑atrial fibrillation stroke causes, or those presenting outside the allowed time windows are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify a timing strategy for starting DOACs that reduces recurrent stroke risk without increasing dangerous brain bleeding.

How similar studies have performed: Observational studies and small randomized trials have examined anticoagulation timing after ischemic stroke, but high-quality randomized evidence specifically following EVT is still limited.

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. No hemorrhagic transformation;
   2. Hemorrhagic infarction type 1 (HI1), defined as small petechiae along the margins of the infarct (Heidelberg classification);
   3. Hemorrhagic infarction type 2 (HI2), defined as confluent petechiae within the infarcted area without space-occupying effect (Heidelberg classification).
6. Time from stroke onset to randomization was within 72 hours.
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.

Where this trial is running

Ma’anshan, Anhui and 39 other locations

• Ma'anshan People's Hospital — Ma’anshan, Anhui, China (RECRUITING)
• Aviation General Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Beijing Shijingshan Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Zhangzhou Municipal Hospital of Fujian Province — Zhangzhou, Fujian, China (RECRUITING)
• Heyuan People's Hospital — Heyuan, Guangdong, China (RECRUITING)
• Qinzhou First People's Hospital — Qinzhou, Guangxi, China (RECRUITING)
• Baoding Sixth Hospital — Baoding, Hebei, China (RECRUITING)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (RECRUITING)
• The Hongda Hospital of Jiamusi University — Jiamusi, Heilongjiang, China (RECRUITING)
• Fangcheng County People's Hospital — Nanyang, Henan, China (RECRUITING)
• Nanyang Central Hospital — Nanyang, Henan, China (RECRUITING)
• Lushan County People's Hospital — Pingdingshan, Henan, China (RECRUITING)
• Xinyang Central Hospital — Xinyang, Henan, China (RECRUITING)
• Queshan County People's Hospital — Zhumadian, Henan, China (RECRUITING)
• Tianyou Hospital, Wuhan University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• The First Affiliated Hospital of Suzhou University — Suzhou, Jiangsu, China (RECRUITING)
• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (RECRUITING)
• Yingkou Central Hospital — Yingkou, Liaoning, China (RECRUITING)
• Ordos Central Hospital — Ordos, Neimenggu, China (RECRUITING)
• Feicheng Hospital Of Shandong Yiyang Health Group — Feicheng, Shandong, China (RECRUITING)
• Jinan Zhangqiu District People's Hospital — Jinan, Shandong, China (RECRUITING)
• Laizhou City People's Hospital — Laizhou, Shandong, China (RECRUITING)
• Liaocheng Neurological Hospital — Liaocheng, Shandong, China (RECRUITING)
• Linyi People's Hospital — Linyi, Shandong, China (RECRUITING)
• Linshu County People's Hospital — Xiazhuang, Shandong, China (RECRUITING)
• Yantai Yeda Hospital — Yantai, Shandong, China (RECRUITING)
• Guoyao Northern Hospital (Baotou) — Baotou, Shanxi, China (RECRUITING)
• ShanXi Cardiovascular Hospital — Taiyuan, Shanxi, China (RECRUITING)
• The Second Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (RECRUITING)
• The People's Hospital of Yueqing — Yueqing, Zhejiang, China (RECRUITING)
• Xuanwu Hospital, Beijing, Beijing 100053 — Beijing, China (RECRUITING)
• Guoluo Prefecture People's Hospital — Guoluo, China (RECRUITING)
• Huanghua Municipal People's Hospital — Huanghua, China (RECRUITING)
• First Affiliated Hospital of Henan Polytechnic University — Jiaozuo, China (RECRUITING)
• Qilu Hospital of Shandong University — Jinan, China (RECRUITING)
• Ningjin County People's Hospital — Ningjin, China (RECRUITING)
• Ren Shou County People's Hospital — Renshou, China (RECRUITING)
• Daliuta Experimental District People's Hospital of Shenmu City — Shenmu, China (RECRUITING)
• Xiuyan Central Hospital — Xiuyan, China (RECRUITING)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, China (RECRUITING)

Study contacts

• Study coordinator: Xunming Ji

Conditions: Ischemic Stroke, Atrial Fibrillation, Endovascular Therapy, Direct oral anticoagulation, Therapy initiation, Randomized Controlled Trial, Stroke