The Incidence of New-brain Lesions on Brain MRI and Safety Between Edoxaban and Apixaban in Patients with Stroke and Nonvalvular Atrial Fibrillation

Launched by EWHA WOMANS UNIVERSITY SEOUL HOSPITAL · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to compare two medications, edoxaban and apixaban, to see if they lead to different rates of new brain lesions in patients who have had a stroke and also have a heart condition called nonvalvular atrial fibrillation. The study will involve brain MRI scans to check for these lesions and will also assess the safety of both medications. It aims to help doctors understand which medication might be better for patients in this situation.

To participate in this trial, individuals need to be 19 years or older and must be stable neurologically at least 14 days after experiencing an ischemic stroke, which is a type of stroke caused by a blockage of blood flow to the brain. Participants must also have a confirmed diagnosis of atrial fibrillation. However, certain patients, such as those with specific health conditions or who are pregnant, will not be eligible. If you join the study, you can expect to undergo some tests, including MRI scans, and receive one of the two medications being studied. This research could contribute to better treatment options for patients with similar health issues in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 19 or over.
• • 2. 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.)
• • 3. Patients with atrial fibrillation confirmed by 12-lead electrocardiogram or Holter's examination for more than 24 hours and nonvalvular atrial fibrillation
• • 4. A person who voluntarily agrees to participate in this clinical trial in writing
• Exclusion Criteria:
• • 1. Patients unable or contraindicated to administer anticoagulants and antithrombotic agents
• • 2. 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
• • 3. A person who is confirmed to be undergoing renal replacement treatment such as dialysis due to acute or terminal nephropathy during screening
• • 4. 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.
• • 5. A person who has been confirmed to be taking medication for liver diseases such as liver cirrhosis during screening
• • 6. 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.
• • 7. A patient with a history of hemorrhagic tendencies, gastrointestinal hemorrhage
• • 8. 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
• • 9. A person who judges that the tester is not appropriate for participation in the clinical trial for other reasons.