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

N/ANot Yet RecruitingNCT06864052

Ewha Womans University Seoul Hospital400 enrolled

Overview

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.

This study is a prospective open randomized clinical trial that can confirm which group the subject was assigned to.After randomization, either the test group or the control group is prescribed, and the outcome variable is checked at 24 months. Therefore, patients who were previously administering edoxaban and apixaban can participate in the study, but if a patient who is administering edoxaban is assigned to apixaban, the drug is taken as apixaban, and similarly, if a patient who is administering apixaban is assigned to an edoxaban, the drug is changed to edoxaban and taken. During clinical trials, testers and researchers carefully observe the occurrence of adverse reactions during the follow-up period after randomization, and closely observe outcome variables, including neurological changes. During the clinical trial period, visits are made after 6, 12, 18, and 24 months, respectively, to check the signs of physical vitality, drug history, side effects, and other research-related events, and brain MR is performed at the 24th month to check the effectiveness and safety. Brain MR can be performed for various reasons before 24 months.In the brain image performed 24 months ago, if the drug is changed or stopped for a long time, the tester plans to first implement appropriate medical measures and then determine whether to continue this study. This clinical trial is a prospective open study and will be conducted in compliance with the usual diagnosis and treatment process, and in particular, all subjects will be properly tested and treated in accordance with the standard treatment guidelines for ischemic stroke during the clinical trial. Subjects may receive active treatment according to the standard treatment guidelines for ischemic stroke during the clinical trial. In stroke patients with nonvalvular atrial fibrillation, NOAC administration is itself a standard practice guideline, so participating in this study does not deviate from the standard treatment guidelines for stroke at all. In principle, when all planned visits are completed, the subject's participation in the clinical trial will be terminated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Stroke Atrial Fibrillation

Interventions

Administration of ApixabanDRUG

Apixaban 2.5mg BID or Apixaban 5mg BID

Administration of EdoxabanDRUG

Edoxaban 15mg QD or Edoxaban 30mg QD or Edoxaban 60mg QD

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ewha Womans University Medical Center

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

Brain MR findings (Differences in the incidence of new brain lesions)

Brain MR findings evaluated at 24 months after the first dose of clinical trial-related drugs (new cerebral infarction (including asymptomatic), white matter hyperintensity, microhemorrhage, etc.)

Time frame: 24 months

Secondary Outcomes

Major cardio-cerebrovascular events

Major cardio-cerebrovascular events that occurred within 12 and 24 months after the first dose of the clinical trial-related drug

Time frame: 12 and 24 months

Modified Rankin scale

Modified Rankin scale evaluated at 12 months and 24 months after the first dose of clinical trial-related drugs. Modified Rankin scale is a total of 7 points scale (0-6). 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.

Time frame: 12 and 24 months

NIHSS (National Institute of Health Stroke Scale)

Changes in NIHSS evaluated at 12 and 24 months after first dose of clinical trial-related drug. NIHSS scale is a total of 43 points scale (0-42) This scale means that the lower the score, the better the prognosis, and the higher the score, the higher the possibility of disability.

Time frame: 12 and 24 months

Other finding of brain MR (Differences in the incidence of new brain lesions)

Other finding of brain MR performed 24 months after the first administration of the clinical trial-related drug (cerebrovascular findings, superficial siderosis, brain volume, etc.)

Central Contacts

Sujin Han Clinical Research Coordinator

CONTACT

82-2-6986-2635 sujinhan1004@gmail.com

Data from ClinicalTrials.gov

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