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Clinical Trials in China / NCT07139314
Recruiting Not applicable

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

NCT07139314 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Not applicable
Started
2025-09-24
Last updated
2026-09-15

Condition(s) studied

Ischemic StrokeAtrial Fibrillation

Investigational drug(s) / intervention(s)

Early anticoagulationDelayed anticoagulation

Early anticoagulation: Early initiation of direct oral anticoagulants will be started within 4 weeks after symptom onset.

Delayed anticoagulation: Delayed initiation of direct oral anticoagulants will be started between 4-8 weeks after symptom onset.

Study 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 who develop hemorrhagic transformation after endovascular treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
Ma'anshan People's Hospital Ma’anshan Anhui Recruiting
Xuanwu Hospital Beijing Beijing Municipality Recruiting
Aviation General Hospital Beijing Beijing Municipality Recruiting
Beijing Shijingshan Hospital Beijing Beijing Municipality Recruiting
Zhangzhou Municipal Hospital of Fujian Province Zhangzhou Fujian Recruiting
Heyuan People's Hospital Heyuan Guangdong Recruiting
Qinzhou First People's Hospital Qinzhou Guangxi Recruiting
Baoding Sixth Hospital Baoding Hebei Recruiting
The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Recruiting
The Hongda Hospital of Jiamusi University Jiamusi Heilongjiang Recruiting
Fangcheng County People's Hospital Nanyang Henan Recruiting
Nanyang Central Hospital Nanyang Henan Recruiting
Lushan County People's Hospital Pingdingshan Henan Recruiting
Xinyang Central Hospital Xinyang Henan Recruiting
Queshan County People's Hospital Zhumadian Henan Recruiting
Tianyou Hospital, Wuhan University of Science and Technology Wuhan Hubei Recruiting
Northern Jiangsu People's Hospital Yangzhou Jiangsu Recruiting
Yingkou Central Hospital Yingkou Liaoning Recruiting
Ordos Central Hospital, Ordos Neimenggu Recruiting
Feicheng Hospital Of Shandong Yiyang Health Group Feicheng Shandong Recruiting
Jinan Zhangqiu District People's Hospital Jinan Shandong Recruiting
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Laizhou City People's Hospital, Laizhou Shandong Recruiting
Linyi People's Hospital Linyi Shandong Recruiting
Linshu County People's Hospital Lishui Shandong Recruiting
Yantai Yeda Hospital Yantai Shandong Recruiting
Guoyao Northern Hospital (Baotou) Baotou Shanxi Recruiting
ShanXi Cardiovascular Hospital Taiyuan Shanxi Recruiting
The Second Affiliated Hospital of Kunming Medical University Kunming Yunnan 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
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

More Capital Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07139314 on ClinicalTrials.gov ↗ ← All trials in China