Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation
NCT ID: NCT07139301
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
438 participants
INTERVENTIONAL
2025-09-04
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation 2
NCT07139314
Endovascular Therapy for Acute Ischemic Stroke Trial
NCT02350283
Early Versus Late Initiation of Anticoagulation in Mild-to-moderate AIS Patients With NVAF
NCT06057467
Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis
NCT06058130
TIMING of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation
NCT02961348
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Early anticoagulation
Early initiation of any direct oral anticoagulant (DOAC) within 96 hours (4 days) of the onset of acute ischemic stroke
Early anticoagulation
Early initiation of direct oral anticoagulants will be started within four days after symptom onset.
Delayed anticoagulation
Delayed initiation of any direct oral anticoagulant (DOAC) between 5-14 days of the onset of acute ischemic stroke
Delayed anticoagulation
Delayed initiation of direct oral anticoagulants will be started between 5-14 days after symptom onset.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Early anticoagulation
Early initiation of direct oral anticoagulants will be started within four days after symptom onset.
Delayed anticoagulation
Delayed initiation of direct oral anticoagulants will be started between 5-14 days after symptom onset.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Capital Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Fei Shi
Role: primary
Chong Li
Role: primary
Zhenyu Kong
Role: primary
Han Wang
Role: primary
Yufeng Jiang
Role: primary
Guoyu Wang
Role: primary
Guangping Li
Role: primary
Yu Feng
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TIMERS-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.