Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation
Recruiting · NCT07139301 · Interventional (participants receive a specific treatment) · Lead sponsor: Capital Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Delayed anticoagulationEarly anticoagulation
What this trial is about
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 emergency endovascular therapy (EVT).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
40 locations listed.
- Xuanwu Hospital, Beijing, Beijing 100053 - Beijing, China
- Guoluo Prefecture People's Hospital - Guoluo, China
- Huanghua Municipal People's Hospital - Huanghua, China
- First Affiliated Hospital of Henan Polytechnic University - Jiaozuo, China
- Qilu Hospital of Shandong University - Jinan, China
- Ningjin County People's Hospital - Ningjin, China
- Ren Shou County People's Hospital - Renshou, China
- Daliuta Experimental District People's Hospital of Shenmu City - Shenmu, China
- Xiuyan Central Hospital - Xiuyan, China
- The Affiliated Hospital of Xuzhou Medical University - Xuzhou, China
- Ma'anshan People's Hospital - Ma’anshan, Anhui, China
- Aviation General Hospital - Beijing, Beijing Municipality, China
- Beijing Shijingshan Hospital - Beijing, Beijing Municipality, China
- Zhangzhou Municipal Hospital of Fujian Province - Zhangzhou, Fujian, China
- Heyuan People's Hospital - Heyuan, Guangdong, China
- Qinzhou First People's Hospital - Qinzhou, Guangxi, China
- Baoding Sixth Hospital - Baoding, Hebei, China
- The First Affiliated Hospital of Harbin Medical University - Harbin, Heilongjiang, China
- The Hongda Hospital of Jiamusi University - Jiamusi, Heilongjiang, China
- Fangcheng County People's Hospital - Nanyang, Henan, China
- Nanyang Central Hospital - Nanyang, Henan, China
- Lushan County People's Hospital - Pingdingshan, Henan, China
- Xinyang Central Hospital - Xinyang, Henan, China
- Queshan County People's Hospital - Zhumadian, Henan, China
- Tianyou Hospital, Wuhan University of Science and Technology - Wuhan, Hubei, China
- The First Affiliated Hospital of Suzhou University - Suzhou, Jiangsu, China
- Northern Jiangsu People's Hospital - Yangzhou, Jiangsu, China
- Yingkou Central Hospital - Yingkou, Liaoning, China
- Ordos Central Hospital - Ordos, Neimenggu, China
- Feicheng Hospital Of Shandong Yiyang Health Group - Feicheng, Shandong, China
- Jinan Zhangqiu District People's Hospital - Jinan, Shandong, China
- Laizhou City People's Hospital - Laizhou, Shandong, China
- Liaocheng Neurological Hospital - Liaocheng, Shandong, China
- Linyi People's Hospital - Linyi, Shandong, China
- Linshu County People's Hospital - Xiazhuang, Shandong, China
- Yantai Yeda Hospital - Yantai, Shandong, China
- Guoyao Northern Hospital (Baotou) - Baotou, Shanxi, China
- ShanXi Cardiovascular Hospital - Taiyuan, Shanxi, China
- The Second Affiliated Hospital of Kunming Medical University - Kunming, Yunnan, China
- The People's Hospital of Yueqing - Yueqing, Zhejiang, China