AzTrials
AzTrials

Ischemic StrokeTIMERS-1NCT07139301

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

A study testing Early anticoagulation and Delayed anticoagulation in people with Ischemic Stroke and Atrial Fibrillation, run by Capital Medical University at 40 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

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 after emergency endovascular therapy (EVT). 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
438 participants
Where
40 sitesChina
Study dates
4 Sep 2025to 18 Oct 2027
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
Show all 14Show fewer
  • 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.

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;
Show all 19Show fewer
  • 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

40 sites in 1 country.

40 sites in 1 country

China40 sites

  • Baoding Sixth Hospital

    Baoding, Hebei

  • Guoyao Northern Hospital (Baotou)

    Baotou, Shanxi

  • Aviation General Hospital

    Beijing, Beijing Municipality

  • Beijing Shijingshan Hospital

    Beijing, Beijing Municipality

  • Xuanwu Hospital, Beijing, Beijing 100053

    Beijing

  • Feicheng Hospital Of Shandong Yiyang Health Group

    Feicheng, Shandong

  • Guoluo Prefecture People's Hospital

    Guoluo

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Heyuan People's Hospital

    Heyuan, Guangdong

  • Huanghua Municipal People's Hospital

    Huanghua

  • The Hongda Hospital of Jiamusi University

    Jiamusi, Heilongjiang

  • First Affiliated Hospital of Henan Polytechnic University

    Jiaozuo

  • Jinan Zhangqiu District People's Hospital

    Jinan, Shandong

  • Qilu Hospital of Shandong University

    Jinan

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Laizhou City People's Hospital

    Laizhou, Shandong

  • Liaocheng Neurological Hospital

    Liaocheng, Shandong

  • Linyi People's Hospital

    Linyi, Shandong

  • Ma'anshan People's Hospital

    Ma’anshan, Anhui

  • Fangcheng County People's Hospital

    Nanyang, Henan

  • Nanyang Central Hospital

    Nanyang, Henan

  • Ningjin County People's Hospital

    Ningjin

  • Ordos Central Hospital

    Ordos, Neimenggu

  • Lushan County People's Hospital

    Pingdingshan, Henan

  • Qinzhou First People's Hospital

    Qinzhou, Guangxi

  • Ren Shou County People's Hospital

    Renshou

  • Daliuta Experimental District People's Hospital of Shenmu City

    Shenmu

  • The First Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu

  • ShanXi Cardiovascular Hospital

    Taiyuan, Shanxi

  • Tianyou Hospital, Wuhan University of Science and Technology

    Wuhan, Hubei

  • Linshu County People's Hospital

    Xiazhuang, Shandong

  • Xinyang Central Hospital

    Xinyang, Henan

  • Xiuyan Central Hospital

    Xiuyan

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

  • Yantai Yeda Hospital

    Yantai, Shandong

  • Yingkou Central Hospital

    Yingkou, Liaoning

  • The People's Hospital of Yueqing

    Yueqing, Zhejiang

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, Fujian

  • Queshan County People's Hospital

    Zhumadian, Henan

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 after emergency endovascular therapy (EVT).

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 after emergency endovascular therapy (EVT).

Being tested
Early anticoagulation, Delayed anticoagulation
Keywords
Endovascular Therapy, Direct oral anticoagulation, Therapy initiation, 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 four days after symptom onset.

  • Delayed anticoagulationDrug

    Delayed initiation of direct oral anticoagulants will be started between 5-14 days after symptom onset.

Study groups in NCT07139301
Study groupRoleWhat they receive
Early anticoagulationExperimentalEarly initiation of any direct oral anticoagulant (DOAC) within 96 hours (4 days) of the onset of acute ischemic stroke
Receives: Drug: Early anticoagulation
Delayed anticoagulationActive comparatorDelayed initiation of any direct oral anticoagulant (DOAC) between 5-14 days 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 (13)

  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 0-1

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

    Measured: 90 days and 1 year

  6. Proportion of Patients Achieving mRS 0-2

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

    Measured: 90 days and 1 year

  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: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicating worse quality of life.

    Measured: 90 days and 1 year

  9. Incidence of vascular death

    Measured: 90 days

  10. All-cause mortality

    Measured: 90 days and 1 year

  11. Incidence of symptomatic intracranial haemorrhage (sICH)

    Measured: 90 days

  12. Incidence of major extracranial bleeding

    Measured: 90 days

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

    Measured: 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 start4 Sep 2025
  3. Primary completion17 Jan 2027 (estimated)
  4. Study completion18 Oct 2027 (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
438 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07139301
Sponsor's protocol ID
TIMERS-1
Acronym
TIMERS-1
Status last verified
Oct 2026
First submitted
17 Aug 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study is proceeding.

Publications

  • Guo Y, Jia X, Liu W, Zhang W, Dong X, Meng R, Ma H, Cui G, Cheng Y, Yi T, Hao J, Jiang Y, Ji X, Feng Y, Wu C. Timing of anticoagulation after emergency endovascular therapy for acute ischaemic stroke with atrial fibrillation (TIMERS): protocol for a randomised controlled trial. BMJ Open. 2026 Sep 9;16(9):e120256. doi: 10.1136/bmjopen-2026-120256.

    PubMed 42716680

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 40 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT07139301, which also lists 1 linked publication.

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 3 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in