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Not yet recruitingNCT07849777EATAFUpdated Sep 30, 2026

Early Anticoagulation Therapy After Endovascular Treatment for Acute Ischemic Stroke With Atrial Fibrillation

An interventional study of Early Initiation of DOAC Therapy and Antiplatelet Bridging Followed by DOAC Therapy in Stroke and Atrial Fibrillation (AF), sponsored by Hao Yonggang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Hao Yonggang · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
474
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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
02

Conditions studied

  • Stroke
  • Atrial Fibrillation (AF)

Keywords

  • stroke
  • endovascular thrombectomy
  • atrial fibrillation
  • randomised controlled trial
  • direct oral anticoagulation
03

Who can participate

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

Inclusion criteria

  1. Age ≥18 years.
  2. Symptom onset within 24 hours before enrollment.
  3. A confirmed diagnosis of acute anterior circulation ischemic stroke.
  4. A baseline NIHSS score ≥6 at admission.
  5. An Alberta Stroke Program Early CT Score (ASPECTS) ≥6.
  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.
  7. Computed tomography (CT) or magnetic resonance imaging (MRI) performed within 24 hours after EVT demonstrating no evidence of hemorrhagic transformation.
  8. Documentation of paroxysmal, persistent, or permanent atrial fibrillation based on electrocardiography or previous medical records.
  9. Written informed consent provided by the patient or a legally authorized representative.

Exclusion criteria

Exclusion Criteria:

  1. Pre-stroke modified Rankin Scale (mRS) score >2.
  2. Valvular atrial fibrillation.
  3. Known hypersensitivity to anticoagulants or any other contraindication to anticoagulant therapy.
  4. Presence of systemic bleeding disorders, coagulopathy, or a platelet count \<100 × 10⁹/L.
  5. Concomitant use of azole antifungal agents, HIV protease inhibitors, or strong CYP3A4 inducers.
  6. Presence of intracranial space-occupying lesions, including intracranial tumors or cerebral vascular malformations.
  7. History of major trauma or major surgery within 1 month before stroke onset.
  8. Evidence of active bleeding within 1 month before stroke onset, including but not limited to gastrointestinal bleeding or genitourinary bleeding.
  9. Cerebral amyloid angiopathy.
  10. 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.
  11. Any terminal illness with an expected life expectancy of less than 6 months.
  12. Breastfeeding women.
  13. Participation in another interventional clinical trial within the previous 3 months.
  14. 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.
04

Study design

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

Study arms

  • Experimental
    Early Initiation of DOAC Therapy

    Other: Early Initiation of DOAC Therapy

  • Experimental
    Antiplatelet Bridging Followed by DOAC Therapy

    Other: Antiplatelet Bridging Followed by DOAC Therapy

Interventions

  • OtherEarly Initiation of DOAC Therapy

    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.

  • OtherAntiplatelet Bridging Followed by DOAC Therapy

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At 90 days after randomization

Secondary outcomes

  1. Composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, or all-cause mortality within 90 days

    Time frame: At 90 days after randomization

  2. Recurrent ischemic stroke within 90 days

    Time frame: At 90 days after randomization

  3. Venous thromboembolic events within 90 days

    Time frame: At 90 days after randomization

  4. Systemic embolic events within 90 days

    Time frame: At 90 days after randomization

  5. Myocardial infarction within 90 days

    Time frame: At 90 days after randomization

  6. 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.

    Time frame: At 90 days after randomization

  7. Symptomatic intracranial hemorrhage within 90 days

    Time frame: At 90 days after randomization

  8. 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.

    Time frame: At 90 days after randomization

  9. Major extracranial bleeding within 90 days

    Time frame: At 90 days after randomization

  10. All-cause mortality within 90 days

    Time frame: At 90 days after randomization

  11. Vascular mortality within 90 days

    Time frame: At 90 days after randomization

06

Study locations

1 site
  • The Fourth Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215000, China
07

References and documents

Study documents

  • Study protocol · Sep 16, 2026

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT07849777
Lead sponsor
Hao Yonggang
Responsible party
Hao Yonggang (Vice Chair of Neurology, The Fourth Affiliated Hospital of Soochow University) — Sponsor-investigator
First posted
Sep 30, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Sep 30, 2029 (estimated)
Completion
Sep 30, 2029 (estimated)
Last update
Sep 30, 2026

Oversight

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

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