Compares edoxaban and apixaban for new brain lesions in stroke patients
Compares two blood-thinning drugs in adults with stroke and irregular heartbeat.
Plain-language title generated from the registry record
Registry title: The Incidence of New-brain Lesions on Brain MRI and Safety Between Edoxaban and Apixaban in Patients with Stroke and Nonvalvular Atrial Fibrillation
Key facts
- Where
- Seoul, South KoreaSee the site
Where in South Korea
- Ewha Womans University Medical CenterSeoul, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ewha Womans University Seoul Hospital
- Trial code
- NCT06864052
- Record updated
- 7 March 2025
- Original description
This study aims to determine whether there is a difference in brain lesion occurrence and safety when brain MRI is followed up between edoxaban and apixaban in stroke patients with nonvalvular atrial fibrillation through exploratory clinical trials.Read full original descriptionShow less
A Randomized, Open-label, Investigator-led, Pilot Trial Investigating the Incidence of New-brain Lesions on Brain MRI and Safety Between Edoxaban and Apixaban in Patients with Stroke and Nonvalvular Atrial Fibrillation
This study aims to determine whether there is a difference in brain lesion occurrence and safety when brain MRI is followed up between edoxaban and apixaban in stroke patients with nonvalvular atrial fibrillation through exploratory clinical trials.
Inclusion: Aged 19 or over; Patients who are neurologically stable 14 days after diagnosis of ischemic stroke and who have undergone brain MRI (including MR diffusion, FLAIR, and GRE sequence) at diagnosis of ischemic stroke (In general, the patient's condition stabilizes within seven days of acute cerebral infarction, but cerebral infarction with atrial fibrillation is more frequent than patients without atrial fibrillation, so we want to target patients with neurological stability after 14 days. Most NOAC-related clinical trials were conducted when the patient's condition became neurologically stable at least two weeks after the stroke.); Patients with atrial fibrillation confirmed by 12-lead electrocardiogram or Holter's examination for more than 24 hours and nonvalvular atrial fibrillation; A person who voluntarily agrees to participate in this clinical trial in writing.
Exclusion: A person who has been diagnosed with cancer within 6 months at the time of screening or has been treated for cancer has been confirmed to have recurrent or metastatic cancer; A person who has been confirmed to be taking medication for liver diseases such as liver cirrhosis during screening; A patient with a history of hemorrhagic tendencies, gastrointestinal hemorrhage; Patients with less than 80,000 platelets, less than 8.0 hemoglobin, liver levels, and total bilirubin levels three times the normal level in the laboratory; A person who is pregnant and nursing. However, women of childbearing age can participate only if it is certain that they are not pregnant. Women of childbearing age are defined as women except those who have not clearly undergone menopause or are unable to conceive by surgical procedures; Patients unable or contraindicated to administer anticoagulants and antithrombotic agents; A person who is confirmed to be undergoing renal replacement treatment such as dialysis due to acute or terminal nephropathy during screening; Patients who have difficulty explaining and expressing their opinions on participation in the study due to decreased consciousness at the time of acquisition of consent; A person who judges that the tester is not appropriate for participation in the clinical trial for other reasons.