The Incidence of New-brain Lesions on Brain MRI and Safety Between Edoxaban and Apixaban in Patie… (NCT06864052) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Incidence of New-brain Lesions on Brain MRI and Safety Between Edoxaban and Apixaban in Patients with Stroke and Nonvalvular Atrial Fibrillation
South Korea400 participantsStarted 2025-03-01
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Patients unable or contraindicated to administer anticoagulants and antithrombotic agents
✕. 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 confirmed to be undergoing renal replacement treatment such as dialysis due to acute or terminal nephropathy during screening
✕. 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
What they're measuring
1
Brain MR findings (Differences in the incidence of new brain lesions)
✕. 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.
✕. A patient with a history of hemorrhagic tendencies, gastrointestinal hemorrhage
✕. 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