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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3,700
non-steroidal anti-inflammatory drugs
orally active direct factor Xa inhibitor
Xijing Hospital
Xi'an, Shaanxi, China
percentage of patients with new stroke (ischemic or hemorrhage)
Time frame: 90 days
Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Time frame: 30 days
mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6
Time frame: 30 days and 90 days
Changes in NIHSS scores
Time frame: 90 days
moderate to severe bleeding events
Time frame: 90 days
Total mortality
Time frame: 90 days
Adverse events/severe adverse events reported by the investigators
Time frame: 90 days
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