StrokeEATAFNCT07849777
Early Anticoagulation Therapy After Endovascular Treatment for Acute Ischemic Stroke With Atrial Fibrillation
A study testing Early Initiation of DOAC Therapy and Antiplatelet Bridging Followed by DOAC Therapy in people with Stroke and Atrial Fibrillation (AF), run by The Fourth Affiliated Hospital of Soochow University at 2 sites in China.
Trial summary
The goal of this clinical trial is to learn whether starting a direct oral anticoagulant (DOAC) early after endovascular treatment works to improve outcomes in patients with ischemic stroke related to atrial fibrillation. It will also learn about the safety of early DOAC treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation (AF)
- What is being tested?
- Early Initiation of DOAC Therapy and Antiplatelet Bridging Followed by DOAC Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 2 sitesChina
- Study dates
- 30 Sep 2026to 30 Sep 2029
- 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
- Age ≥18 years.
- Symptom onset within 24 hours before enrollment.
- A confirmed diagnosis of acute anterior circulation ischemic stroke.
- A baseline NIHSS score ≥6 at admission.
- An Alberta Stroke Program Early CT Score (ASPECTS) ≥6.
- Computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA) confirming occlusion of the intracranial internal carotid artery (ICA) or the M1/M2 segment of the middle cerebral artery (MCA), with the patient scheduled to undergo EVT.
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- Computed tomography (CT) or magnetic resonance imaging (MRI) performed within 24 hours after EVT demonstrating no evidence of hemorrhagic transformation.
- Documentation of paroxysmal, persistent, or permanent atrial fibrillation based on electrocardiography or previous medical records.
- Written informed consent provided by the patient or a legally authorized representative.
Who cannot join
- Pre-stroke modified Rankin Scale (mRS) score >2.
- Valvular atrial fibrillation.
- Known hypersensitivity to anticoagulants or any other contraindication to anticoagulant therapy.
- Presence of systemic bleeding disorders, coagulopathy, or a platelet count <100 × 10⁹/L.
- Concomitant use of azole antifungal agents, HIV protease inhibitors, or strong CYP3A4 inducers.
- Presence of intracranial space-occupying lesions, including intracranial tumors or cerebral vascular malformations.
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- History of major trauma or major surgery within 1 month before stroke onset.
- Evidence of active bleeding within 1 month before stroke onset, including but not limited to gastrointestinal bleeding or genitourinary bleeding.
- Cerebral amyloid angiopathy.
- Severe hepatic or renal impairment, or receipt of dialysis for any cause. Severe hepatic impairment is defined as alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN) or aspartate aminotransferase (AST) >3× ULN. Severe renal impairment is defined as serum creatinine >3.0 mg/dL (265.2 μmol/L) or an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
- Any terminal illness with an expected life expectancy of less than 6 months.
- Breastfeeding women.
- Participation in another interventional clinical trial within the previous 3 months.
- Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study or interfere with study participation or completion, including but not limited to psychiatric disorders, cognitive or emotional impairment, or physical conditions that preclude adherence to study procedures or follow-up.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Department of Neurology, Huashan Hospital, Fudan University
Shanghai, 200000
Jianhui Fu, +8613701818645, jianhuifu@126.com
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Qi Fang, 051265955410, fangqi_008@126.com
About this study
The goal of this clinical trial is to learn whether starting a direct oral anticoagulant (DOAC) early after endovascular treatment works to improve outcomes in patients with ischemic stroke related to atrial fibrillation. It will also learn about the safety of early DOAC treatment. The main question it aims to answer is:
- Does starting DOAC treatment 24 hours after endovascular treatment improve outcomes at 3 months compared with starting it 5 days after randomization?
Read more
Researchers will compare early DOAC treatment (started 24 hours after the procedure) with delayed DOAC treatment (started 5 days after randomization) to see if early treatment works better.
Participants will:
- Have atrial fibrillation-related acute ischemic stroke caused by a large vessel blockage in the front part of the brain, within 24 hours of symptom onset
- Be randomly assigned to one of two groups after endovascular treatment: early DOAC treatment or delayed DOAC treatment
- Take DOACs starting 24 hours after the procedure (early group) or 5 days after randomization (delayed group)
- Be followed up for 3 months to check their recovery and any medical problems
- Conditions
- Stroke, Atrial Fibrillation (AF)
- Being tested
- Early Initiation of DOAC Therapy, Antiplatelet Bridging Followed by DOAC Therapy
- Keywords
- stroke, endovascular thrombectomy, atrial fibrillation, randomised controlled trial, direct oral anticoagulation
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Initiation of DOAC TherapyOther
Participants assigned to the intervention group will initiate DOAC therapy 24 hours after endovascular therapy (EVT). For patients receiving antiplatelet therapy before enrollment, antiplatelet agents will be discontinued upon initiation of DOAC therapy.
Antiplatelet Bridging Followed by DOAC TherapyOther
DOAC therapy will be initiated 5 days after randomization. Before DOAC initiation, patients will receive bridging therapy with a single antiplatelet agent, consisting of either aspirin 100 mg once daily or clopidogrel 75 mg once daily. Dual antiplatelet therapy is not permitted. Antiplatelet therapy will be discontinued upon initiation of DOAC therapy.
| Study group | Role | What they receive |
|---|---|---|
| Early Initiation of DOAC Therapy | Experimental | Not described Receives: Other: Early Initiation of DOAC Therapy |
| Antiplatelet Bridging Followed by DOAC Therapy | Experimental | Not described Receives: Other: Antiplatelet Bridging Followed by DOAC Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence (90-day mRS score ≤ 1)
Modified Rankin Scale (mRS). Scores range from 0 to 6, with 0 indicating no symptoms and 6 indicating death. Higher scores indicate a worse outcome.
Measured: At 90 days after randomization
Secondary outcomes (11)
Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, or all-cause mortality within 90 days
Measured: At 90 days after randomization
Recurrent ischemic stroke within 90 days
Measured: At 90 days after randomization
Venous thromboembolic events within 90 days
Measured: At 90 days after randomization
Systemic embolic events within 90 days
Measured: At 90 days after randomization
Myocardial infarction within 90 days
Measured: At 90 days after randomization
Favorable functional outcome (90-day mRS score ≤ 2)
Modified Rankin Scale (mRS). Scores range from 0 to 6, with 0 indicating no symptoms and 6 indicating death. Higher scores indicate a worse outcome.
Measured: At 90 days after randomization
Symptomatic intracranial hemorrhage within 90 days
Measured: At 90 days after randomization
Health-related quality of life at 90 days, assessed using the EQ-5D-3L questionnaire
Health-related quality of life (HRQoL) was assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire. The EQ-5D-3L descriptive system evaluates the state of general health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, using three levels to indicate the extent of problems: no problems, some/moderate problems, and severe problems. The EQ-5D-3L utility score is a single score calculated using population-based preference weights for each dimension, and expressed as a fraction of perfect health, with a score of 1 representing perfect health, 0 representing death, and negative scores (with a minimum score of -0.109) indicating health states considered worse than death. The average utility score in disease-free populations range between 0.8 and 0.9.
Measured: At 90 days after randomization
Major extracranial bleeding within 90 days
Measured: At 90 days after randomization
All-cause mortality within 90 days
Measured: At 90 days after randomization
Vascular mortality within 90 days
Measured: At 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital
- Responsible party
- Principal investigator, Hao Yonggang, The Fourth Affiliated Hospital of Soochow University
- Investigators
- Qi Fang, Study chair, The Fourth Affiliated Hospital of Soochow UniversityJianhui Fu, Study chair, Huashan HospitalYonggang Hao, Principal investigator, The Fourth Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849777
- Sponsor's protocol ID
- 2026-072-01
- Acronym
- EATAF
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Anticoagulation Therapy After Endovascular Treatment for Acute Ischemic Stroke With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07849777
- Acronym / sponsor ID
- EATAF / 2026-072-01
- Conditions
- Stroke, Atrial Fibrillation (AF)
- Keywords
- stroke, endovascular thrombectomy, atrial fibrillation, randomised controlled trial, direct oral anticoagulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Huashan Hospital
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether starting a direct oral anticoagulant (DOAC) early after endovascular treatment works to improve outcomes in patients with ischemic stroke related to atrial fibrillation. It will also learn about the safety of early DOAC treatment. The main question it aims to answer is:
- Does starting DOAC treatment 24 hours after endovascular treatment improve outcomes at 3 months compared with starting it 5 days after randomization?
Researchers will compare early DOAC treatment (started 24 hours after the procedure) with delayed DOAC treatment (started 5 days after randomization) to see if early treatment works better.
Participants will:
- Have atrial fibrillation-related acute ischemic stroke caused by a large vessel blockage in the front part of the brain, within 24 hours of symptom onset
- Be randomly assigned to one of two groups after endovascular treatment: early DOAC treatment or delayed DOAC treatment
- Take DOACs starting 24 hours after the procedure (early group) or 5 days after randomization (delayed group)
- Be followed up for 3 months to check their recovery and any medical problems
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Initiation of DOAC Therapy | Experimental | Other: Early Initiation of DOAC Therapy |
| Antiplatelet Bridging Followed by DOAC Therapy | Experimental | Other: Antiplatelet Bridging Followed by DOAC Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years.
- Symptom onset within 24 hours before enrollment.
- A confirmed diagnosis of acute anterior circulation ischemic stroke.
- A baseline NIHSS score ≥6 at admission.
- An Alberta Stroke Program Early CT Score (ASPECTS) ≥6.
Key exclusion criteria (14 listed)
- Pre-stroke modified Rankin Scale (mRS) score >2.
- Valvular atrial fibrillation.
- Known hypersensitivity to anticoagulants or any other contraindication to anticoagulant therapy.
- Presence of systemic bleeding disorders, coagulopathy, or a platelet count <100 × 10⁹/L.
- Concomitant use of azole antifungal agents, HIV protease inhibitors, or strong CYP3A4 inducers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Initiation of DOAC TherapyParticipants assigned to the intervention group will initiate DOAC therapy 24 hours after endovascular therapy (EVT). For patients receiving antiplatelet therapy before enrollment, antiplatelet agents will be discontinued upon initiation of DOAC therapy. | Other | Early Initiation of DOAC Therapy |
| Antiplatelet Bridging Followed by DOAC TherapyDOAC therapy will be initiated 5 days after randomization. Before DOAC initiation, patients will receive bridging therapy with a single antiplatelet agent, consisting of either aspirin 100 mg once daily or clopidogrel 75 mg once daily. Dual antiplatelet therapy is not permitted. Antiplatelet therapy will be discontinued upon initiation of DOAC therapy. | Other | Antiplatelet Bridging Followed by DOAC Therapy |
Primary outcome
Functional independence (90-day mRS score ≤ 1)
Time frame: At 90 days after randomization
Modified Rankin Scale (mRS). Scores range from 0 to 6, with 0 indicating no symptoms and 6 indicating death. Higher scores indicate a worse outcome.
11 secondary outcomes
Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, or all-cause mortality within 90 days
Time frame: At 90 days after randomization
Recurrent ischemic stroke within 90 days
Time frame: At 90 days after randomization
Venous thromboembolic events within 90 days
Time frame: At 90 days after randomization
Systemic embolic events within 90 days
Time frame: At 90 days after randomization
Myocardial infarction within 90 days
Time frame: At 90 days after randomization
Favorable functional outcome (90-day mRS score ≤ 2)
Time frame: At 90 days after randomization
Symptomatic intracranial hemorrhage within 90 days
Time frame: At 90 days after randomization
Health-related quality of life at 90 days, assessed using the EQ-5D-3L questionnaire
Time frame: At 90 days after randomization
Major extracranial bleeding within 90 days
Time frame: At 90 days after randomization
All-cause mortality within 90 days
Time frame: At 90 days after randomization
Vascular mortality within 90 days
Time frame: At 90 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qi Fang study chair
The Fourth Affiliated Hospital of Soochow University
Jianhui Fu study chair
Huashan Hospital
Yonggang Hao principal investigator
The Fourth Affiliated Hospital of Soochow University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Initiation of DOAC Therapy and Antiplatelet Bridging Followed by DOAC Therapy in people with Stroke and Atrial Fibrillation (AF), run by The Fourth Affiliated Hospital of Soochow University at 2 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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Qi Fang (051265955410, fangqi_008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence (90-day mRS score ≤ 1) (time frame: At 90 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.