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Search / Trial NCT07139301

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

Launched by CAPITAL MEDICAL UNIVERSITY · Aug 17, 2025

Trial Information

Current as of September 07, 2025

Not yet recruiting

Keywords

Endovascular Therapy Direct Oral Anticoagulation Therapy Initiation Randomized Controlled Trial Stroke

ClinConnect Summary

This clinical trial is studying the best time to start blood-thinning medication called direct oral anticoagulants (DOACs) in people who have had a stroke caused by a blocked blood vessel and who also have a heart condition called atrial fibrillation. These medications help prevent new blood clots but can also increase the risk of bleeding. The study aims to find out whether starting these medicines early or waiting a little longer after emergency treatment to open the blocked vessel is safer and more effective.

People who might be eligible for this study are adults who recently had a specific type of stroke treated with an emergency procedure to remove the blockage, and who have confirmed atrial fibrillation. To join, patients need to have certain brain scan results showing no or only minor bleeding after their stroke and must be able to start the study within three days of their stroke. Participants will be carefully monitored over the next few months to see how they respond to early versus delayed blood-thinner treatment. This study is not yet recruiting, and the researchers will ensure that only those who can safely take these medications and complete follow-up visits are included.

Gender

ALL

Eligibility criteria

  • 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 ECG 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. No hemorrhagic transformation;
  • 2. Hemorrhagic infarction type 1 (HI1), defined as small petechiae along the margins of the infarct (Heidelberg classification);
  • 3. Hemorrhagic infarction type 2 (HI2), defined as confluent petechiae within the infarcted area without space-occupying effect (Heidelberg classification).
  • 6. Time from stroke onset to randomization was within 72 hours.
  • 7. Written informed consent obtained from the patient or a legally authorized representative.
  • Exclusion Criteria:
  • 1. Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, or myocardial infarct).
  • 2. Contraindication 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 upper limit of normal range) and significant hepatic dysfunction (defined as ALT or AST \> twice the upper limit of normal range) ;
  • 4. Concomitant use of medications with significant interactions with DOACs, including azole antifungals, HIV protease inhibitors, or strong CYP3A4 inducers;
  • 5. Baseline platelet 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 INR ≥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.

About Capital Medical University

Capital Medical University is a leading institution in medical education and research, dedicated to advancing healthcare through innovative clinical trials. With a strong emphasis on scientific rigor and ethical standards, the university collaborates with a network of healthcare professionals and researchers to drive breakthroughs in medical science. Capital Medical University aims to enhance patient care and improve health outcomes by fostering a multidisciplinary approach to clinical research, ensuring that its trials are designed to address critical health challenges and contribute valuable insights to the medical community.

Locations

Beijing, , China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported