Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation 2
TIMERS-2
1 other identifier
interventional
240
1 country
37
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 who develop hemorrhagic transformation after endovascular treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2025
CompletedFirst Posted
Study publicly available on registry
August 24, 2025
CompletedStudy Start
First participant enrolled
September 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
February 5, 2026
February 1, 2026
11 months
August 17, 2025
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, and all-cause death
90 days
Secondary Outcomes (12)
Incidence of recurrent ischemic stroke
90 days
Incidence of venous thromboembolism
90 days
Incidence of systemic embolism
90 days
Incidence of myocardial infarction
90 days
Proportion of patients achieving mRS 0-2 at 90 Days
90 days
- +7 more secondary outcomes
Study Arms (2)
Early anticoagulation
ACTIVE COMPARATOREarly initiation of any direct oral anticoagulant (DOAC) within 4 weeks of the onset of acute ischemic stroke
Delayed anticoagulation
EXPERIMENTALDelayed initiation of any direct oral anticoagulant (DOAC) between 4-8 weeks of the onset of acute ischemic stroke
Interventions
Early initiation of direct oral anticoagulants will be started within 4 weeks after symptom onset.
Delayed initiation of direct oral anticoagulants will be started between 4-8 weeks after symptom onset.
Eligibility Criteria
You may qualify if:
- 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:
- 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:
- Parenchymatous hematoma type 1: defined as hematoma occupying less than 30% of the infarcted tissue, no substantive mass effect (Heidelberg classification);
- Parenchymatous hematoma type 2: defined as heamtoma occupying 30% or more of the infarcted tissue, with obvious mass effect (Heidelberg classification);
- Intracerebral hemorrhage outside the infarcted brain tissue or intracranial-extracerebral hemorrhage (Heidelberg classification).
- Time from stroke onset to randomization ranged from 7 days to 4 weeks.
- Written informed consent obtained from the patient or a legally authorized representative.
You may not qualify if:
- 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).
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Ma'anshan People's Hospital
Ma’anshan, Anhui, China
Xuanwu Hospital
Beijing, Beijing Municipality, 100053, 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
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
Qilu Hospital of Shandong University
Jinan, Shandong, China
Laizhou City People's Hospital,
Laizhou, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Linshu County People's Hospital
Lishui, 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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology, Xuanwu Hospital, Capital Medical University
Study Record Dates
First Submitted
August 17, 2025
First Posted
August 24, 2025
Study Start
September 24, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
The study is proceeding.