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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of Apixaban | Experimental | The intervention group will receive Apixaban 2.5mg or Apixaban 5mg |
|
| Administration of Edoxaban | Other | The control group will receive Edoxaban 15mg or 30mg or 60mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of Apixaban | Drug | Apixaban 2.5mg BID or Apixaban 5mg BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 and 24 months |
| Modified Rankin scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sujin Han Clinical Research Coordinator | Contact | 82-2-6986-2635 | sujinhan1004@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University Medical Center | Seoul | Seoul | 07804 | South Korea |
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| Administration of Edoxaban |
| Drug |
Edoxaban 15mg QD or Edoxaban 30mg QD or Edoxaban 60mg QD |
|
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.
| 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. | 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.) | 24 months |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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