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Ischemic StrokeTIMERS-2NCT07139314

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

A study testing Early anticoagulation and Delayed anticoagulation in people with Ischemic Stroke and Atrial Fibrillation, run by Capital Medical University at 37 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Atrial Fibrillation
What is being tested?
Early anticoagulation and Delayed anticoagulation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
37 sitesChina
Study dates
24 Sep 2025to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

37 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xunming Ji contact

01083198962

jixm@ccmu.edu.cn

Chuanjie Wu contact

01083199439

wuchuanjie@ccmu.edu.cn

37 sites in 1 country

China37 sites, 37 recruiting

  • Baoding Sixth Hospital

    Baoding, Hebei

    Jing Chen

    Recruiting

  • Guoyao Northern Hospital (Baotou)

    Baotou, Shanxi

    Yude Zhu

    Recruiting

  • Xuanwu Hospital

    Beijing, Beijing Municipality, 100053

    Chuanjie Wu, 01083199439, wuchuanjie@ccmu.edu.cn

    Xunming Ji, 01083198962, jixm@ccmu.edu.cn

    Recruiting

  • Aviation General Hospital

    Beijing, Beijing Municipality

    Li Xu

    Recruiting

  • Beijing Shijingshan Hospital

    Beijing, Beijing Municipality

    Xifang Song

    Recruiting

  • Feicheng Hospital Of Shandong Yiyang Health Group

    Feicheng, Shandong

    Chuanliang Chang

    Recruiting

  • Guoluo Prefecture People's Hospital

    Guoluo

    Fei Shi

    Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Guang Zhang

    Recruiting

  • Heyuan People's Hospital

    Heyuan, Guangdong

    Wensheng Zhang

    Recruiting

  • Huanghua Municipal People's Hospital

    Huanghua

    Chong Li

    Recruiting

  • The Hongda Hospital of Jiamusi University

    Jiamusi, Heilongjiang

    Changsi Ai

    Recruiting

  • First Affiliated Hospital of Henan Polytechnic University

    Jiaozuo

    Zhenyu Kong

    Recruiting

  • Jinan Zhangqiu District People's Hospital

    Jinan, Shandong

    Bin Ma

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    Wei Wu

    Recruiting

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Juan Bao

    Recruiting

  • Laizhou City People's Hospital,

    Laizhou, Shandong

    Jundong Yang

    Recruiting

  • Linyi People's Hospital

    Linyi, Shandong

    Xianjun Wang

    Recruiting

  • Linshu County People's Hospital

    Lishui, Shandong

    Shoujun Ma

    Recruiting

  • Ma'anshan People's Hospital

    Ma’anshan, Anhui

    Jing Xu

    Recruiting

  • Fangcheng County People's Hospital

    Nanyang, Henan

    Huayi Tian

    Recruiting

  • Nanyang Central Hospital

    Nanyang, Henan

    Yifeng Liu

    Recruiting

  • Ningjin County People's Hospital

    Ningjin

    Han Wang

    Recruiting

  • Ordos Central Hospital,

    Ordos, Neimenggu

    Yingchun Wu

    Recruiting

  • Lushan County People's Hospital

    Pingdingshan, Henan

    Wenhao Zuo

    Recruiting

  • Qinzhou First People's Hospital

    Qinzhou, Guangxi

    Ke Ma

    Recruiting

  • Ren Shou County People's Hospital

    Renshou

    Yufeng Jiang

    Recruiting

  • Daliuta Experimental District People's Hospital of Shenmu City

    Shenmu

    Guoyu Wang

    Recruiting

  • ShanXi Cardiovascular Hospital

    Taiyuan, Shanxi

    Qiong Hu

    Recruiting

  • Tianyou Hospital, Wuhan University of Science and Technology

    Wuhan, Hubei

    Xing Wang

    Recruiting

  • Xinyang Central Hospital

    Xinyang, Henan

    Jialiang Zhang

    Recruiting

  • Xiuyan Central Hospital

    Xiuyan

    Guangping Li

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

    Yu Feng

    Guiyun Cui

    Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

    Xiaobo Li

    Recruiting

  • Yantai Yeda Hospital

    Yantai, Shandong

    Wenjun Qian

    Recruiting

  • Yingkou Central Hospital

    Yingkou, Liaoning

    Ye Wang

    Recruiting

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, Fujian

    Tingyu Yi

    Recruiting

  • Queshan County People's Hospital

    Zhumadian, Henan

    Qiang Chen

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

This is a multicenter, prospective, open-label, randomized controlled trial evaluating the safety and efficacy of different initiation timings of direct oral anticoagulants (DOACs) therapy in patients with acute ischemic stroke related to atrial fibrillation who develop hemorrhagic transformation after emergency endovascular therapy (EVT).

Being tested
Early anticoagulation, Delayed anticoagulation
Keywords
Endovascular therapy, Direct oral anticoagulation, Therapy initiation, Hemorrhagic transformation, Randomized Controlled Trial, Stroke
Medical subject headings
Ischemic Stroke, Atrial Fibrillation, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early anticoagulationDrug

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

  • Delayed anticoagulationDrug

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

Study groups in NCT07139314
Study groupRoleWhat they receive
Early anticoagulationActive comparatorEarly initiation of any direct oral anticoagulant (DOAC) within 4 weeks of the onset of acute ischemic stroke
Receives: Drug: Early anticoagulation
Delayed anticoagulationExperimentalDelayed initiation of any direct oral anticoagulant (DOAC) between 4-8 weeks of the onset of acute ischemic stroke
Receives: Drug: Delayed anticoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, and all-cause death

    Measured: 90 days

Secondary outcomes (12)

  1. Incidence of recurrent ischemic stroke

    Measured: 90 days and 1 year

  2. Incidence of venous thromboembolism

    Measured: 90 days

  3. Incidence of systemic embolism

    Measured: 90 days

  4. Incidence of myocardial infarction

    Measured: 90 days

  5. Proportion of patients achieving mRS 0-2

    The modified Rankin scale (range, 0 [no symptoms] to 6 [death])

    Measured: 90 days and 1 year

  6. Proportion of patients achieving mRS 0-3 at 90 Days

    The modified Rankin scale (range, 0 [no symptoms] to 6 [death])

    Measured: 90 days

  7. Length of hospital stay for stroke-related care

    Measured: 90 days

  8. Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire [EQ-5D-5L]

    The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.

    Measured: 90 days and 1 year

  9. Incidence of vascular death

    Measured: 90 days and 1 year

  10. All-cause mortality

    Measured: 90 days and 1 year

  11. Incidence of symptomatic intracranial hemorrhage (sICH)

    Measured: 90 days and 1 year

  12. Incidence of major extracranial bleeding

    Measured: 90 days and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2025
  2. Study start24 Sep 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07139314
Sponsor's protocol ID
TIMERS-2
Acronym
TIMERS-2
Status last verified
Feb 2026
First submitted
17 Aug 2025
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study is proceeding.

Questions about this trial

What is this clinical trial studying?

A study testing Early anticoagulation and Delayed anticoagulation in people with Ischemic Stroke and Atrial Fibrillation, run by Capital Medical University at 37 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xunming Ji (01083198962, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, and all-cause death (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07139314.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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