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Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and slightly increase the risk of intracerebral hemorrhage. Recently, edoxaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying significantly less risk of intracranial hemorrhage.
This trial is a randomized, double-blind, multicenter, controlled clinical trial in China. The investigators will assess the hypothesis that a 30-days edoxaban regimen is superior to aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aspirin | Active Comparator | Receiving a 100-mg dose of aspirin and placebo edoxaban from day 1 to day 30 |
|
| edoxaban 30mg | Experimental | Receiving a 30-mg dose of edoxaban and placebo aspirin from day 1 to day 30 |
|
| edoxaban 60mg | Experimental | Receiving a 60-mg dose of edoxaban and placebo aspirin from day 1 to day 30 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | non-steroidal anti-inflammatory drugs |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients with new stroke (ischemic or hemorrhage) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) | 30 days | |
| mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6 | 30 days and 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuedong Liu | Contact | +86 029 84775055 | liuxued@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gang Zhao, M.D. | Xijing hostipal | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| D020521 | Stroke |
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| C552171 | edoxaban |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| edoxaban | Drug | orally active direct factor Xa inhibitor |
|
|
| placebo | Drug |
|
| Changes in NIHSS scores | 90 days |
| moderate to severe bleeding events | 90 days |
| Total mortality | 90 days |
| Adverse events/severe adverse events reported by the investigators | 90 days |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D009336 | Necrosis |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |