ClinicalTrials.gg
RecruitingNCT07139314TIMERS-2Updated Sep 15, 2026

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

An interventional study of Early anticoagulation and Delayed anticoagulation in Ischemic Stroke and Atrial Fibrillation, sponsored by Capital Medical University. Recruiting at 37 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Capital Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 45 studies in Ischemic Stroke by Capital Medical University — 20 open to participants now, 25 under way, 10 of them phase 3. Ischemic Stroke · Capital Medical University.

Planned enrollment
18th of 39
240 · median 208
Started
2025
with 9 others
No phase
14 of 45
6 open now
Primary completion
2026-11
later than 7 of 24 live
Registered
30th of 45
by date

Among the 45 studies in Ischemic Stroke by Capital Medical University, this one is the 18th largest by planned enrollment of the 39 interventional ones that give a count, is one of 10 that started in 2025, is one of 14 with no phase, reaches primary completion later than 7 of the 24 other live ones, and was the 30th registered.

Ischemic Stroke

2,617 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.

Browse Ischemic Stroke studies →

Open to participants now

20 of the 45 studies in Ischemic Stroke by Capital Medical University are open now, in 1 country. Recruiting first, the newest first:

14 more — sign in →

By country, each count listing its studies:

All 20 open studies →

Where they have run

Who these studies take

Of the 661 Ischemic Stroke studies recruiting now, 396 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 42 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 45 studies in Ischemic Stroke by Capital Medical University, or all of them as a file.
02

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.

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).

03

Conditions studied

  • Ischemic Stroke
  • Atrial Fibrillation

Keywords

  • Endovascular therapy
  • Direct oral anticoagulation
  • Therapy initiation
  • Hemorrhagic transformation
  • Randomized Controlled Trial
  • Stroke
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 obtained from the patient or a legally authorized representative.

Exclusion criteria

Exclusion Criteria:

  1. Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, or myocardial infarct).
  2. 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 ) and significant hepatic dysfunction (defined as or AST > twice the upper limit of normal range) ;
    4. Concomitant use of medications with significant interactions with DOACs, including azole antifungals, protease inhibitors, or strong inducers;
    5. Baseline 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 ≥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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Active comparator
    Early anticoagulation

    Early initiation of any direct oral anticoagulant (DOAC) within 4 weeks of the onset of acute ischemic stroke

    Drug: Early anticoagulation

  • Experimental
    Delayed anticoagulation

    Delayed initiation of any direct oral anticoagulant (DOAC) between 4-8 weeks of the onset of acute ischemic stroke

    Drug: Delayed anticoagulation

Interventions

  • DrugEarly anticoagulation

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

  • DrugDelayed anticoagulation

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

06

What researchers measure

Primary outcomes

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

    Time frame: 90 days

Secondary outcomes

  1. Incidence of recurrent ischemic stroke

    Time frame: 90 days and 1 year

  2. Incidence of venous thromboembolism

    Time frame: 90 days

  3. Incidence of systemic embolism

    Time frame: 90 days

  4. Incidence of myocardial infarction

    Time frame: 90 days

  5. Proportion of patients achieving mRS 0-2

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

    Time frame: 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 \[death\])

    Time frame: 90 days

  7. Length of hospital stay for stroke-related care

    Time frame: 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.

    Time frame: 90 days and 1 year

  9. Incidence of vascular death

    Time frame: 90 days and 1 year

  10. All-cause mortality

    Time frame: 90 days and 1 year

  11. Incidence of symptomatic intracranial hemorrhage (sICH)

    Time frame: 90 days and 1 year

  12. Incidence of major extracranial bleeding

    Time frame: 90 days and 1 year

Other outcomes

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

    Time frame: 1 year

07

Study locations

37 of 37 sites recruiting
  • Ma'anshan People's Hospital
    Ma’anshan, Anhui, China
    Recruiting
    • Jing Xu · Contact
  • Xuanwu Hospital
    Beijing, Beijing Municipality 100053, China
    Recruiting
  • Aviation General Hospital
    Beijing, Beijing Municipality, China
    Recruiting
    • Li Xu · Contact
  • Beijing Shijingshan Hospital
    Beijing, Beijing Municipality, China
    Recruiting
    • Xifang Song · Contact
  • Zhangzhou Municipal Hospital of Fujian Province
    Zhangzhou, Fujian, China
    Recruiting
    • Tingyu Yi · Contact
  • Heyuan People's Hospital
    Heyuan, Guangdong, China
    Recruiting
    • Wensheng Zhang · Contact
  • Qinzhou First People's Hospital
    Qinzhou, Guangxi, China
    Recruiting
    • Ke Ma · Contact
  • Baoding Sixth Hospital
    Baoding, Hebei, China
    Recruiting
    • Jing Chen · Contact
  • The First Affiliated Hospital of Harbin Medical University
    Harbin, Heilongjiang, China
    Recruiting
    • Guang Zhang · Contact
  • The Hongda Hospital of Jiamusi University
    Jiamusi, Heilongjiang, China
    Recruiting
    • Changsi Ai · Contact
  • Fangcheng County People's Hospital
    Nanyang, Henan, China
    Recruiting
    • Huayi Tian · Contact
  • Nanyang Central Hospital
    Nanyang, Henan, China
    Recruiting
    • Yifeng Liu · Contact
  • Lushan County People's Hospital
    Pingdingshan, Henan, China
    Recruiting
    • Wenhao Zuo · Contact
  • Xinyang Central Hospital
    Xinyang, Henan, China
    Recruiting
    • Jialiang Zhang · Contact
  • Queshan County People's Hospital
    Zhumadian, Henan, China
    Recruiting
    • Qiang Chen · Contact
  • Tianyou Hospital, Wuhan University of Science and Technology
    Wuhan, Hubei, China
    Recruiting
    • Xing Wang · Contact
  • Northern Jiangsu People's Hospital
    Yangzhou, Jiangsu, China
    Recruiting
    • Xiaobo Li · Contact
  • Yingkou Central Hospital
    Yingkou, Liaoning, China
    Recruiting
    • Ye Wang · Contact
  • Ordos Central Hospital,
    Ordos, Neimenggu, China
    Recruiting
    • Yingchun Wu · Contact
  • Feicheng Hospital Of Shandong Yiyang Health Group
    Feicheng, Shandong, China
    Recruiting
    • Chuanliang Chang · Contact
  • Jinan Zhangqiu District People's Hospital
    Jinan, Shandong, China
    Recruiting
    • Bin Ma · Contact
  • Qilu Hospital of Shandong University
    Jinan, Shandong, China
    Recruiting
    • Wei Wu · Contact
  • Laizhou City People's Hospital,
    Laizhou, Shandong, China
    Recruiting
    • Jundong Yang · Contact
  • Linyi People's Hospital
    Linyi, Shandong, China
    Recruiting
    • Xianjun Wang · Contact
  • Linshu County People's Hospital
    Lishui, Shandong, China
    Recruiting
    • Shoujun Ma · Contact
  • Yantai Yeda Hospital
    Yantai, Shandong, China
    Recruiting
    • Wenjun Qian · Contact
  • Guoyao Northern Hospital (Baotou)
    Baotou, Shanxi, China
    Recruiting
    • Yude Zhu · Contact
  • ShanXi Cardiovascular Hospital
    Taiyuan, Shanxi, China
    Recruiting
    • Qiong Hu · Contact
  • The Second Affiliated Hospital of Kunming Medical University
    Kunming, Yunnan, China
    Recruiting
    • Juan Bao · Contact
  • Guoluo Prefecture People's Hospital
    Guoluo, China
    Recruiting
    • Fei Shi · Contact
  • Huanghua Municipal People's Hospital
    Huanghua, China
    Recruiting
    • Chong Li · Contact
  • First Affiliated Hospital of Henan Polytechnic University
    Jiaozuo, China
    Recruiting
    • Zhenyu Kong · Contact
  • Ningjin County People's Hospital
    Ningjin, China
    Recruiting
    • Han Wang · Contact
  • Ren Shou County People's Hospital
    Renshou, China
    Recruiting
    • Yufeng Jiang · Contact
  • Daliuta Experimental District People's Hospital of Shenmu City
    Shenmu, China
    Recruiting
    • Guoyu Wang · Contact
  • Xiuyan Central Hospital
    Xiuyan, China
    Recruiting
    • Guangping Li · Contact
  • The Affiliated Hospital of Xuzhou Medical University
    Xuzhou, China
    Recruiting
    • Yu Feng · Contact
    • Guiyun Cui · Contact
08

References and documents

Individual participant data

Plan to share: No — The study is proceeding.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Nov 2026, 14 months after the start.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 14 months is below that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2025
First posted
Aug 24, 2025
StartActual
Sep 24, 2025
Primary completionEst.
Nov 30, 2026
CompletionEst.
Nov 30, 2026
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07139314
Responsible party
Ji Xunming,MD,PhD (Professor of Neurology, Xuanwu Hospital, Capital Medical University, Capital Medical University) — Principal investigator
First posted
Aug 24, 2025
Start date
Sep 24, 2025
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Sep 15, 2026

Study contacts

Xunming Ji
Contact
jixm@ccmu.edu.cn
01083198962
Chuanjie Wu
Contact
wuchuanjie@ccmu.edu.cn
01083199439

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion