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, rivaroxaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying significantly less risk of intracranial hemorrhage. The TRACE trial is a randomized, double-blind, multicenter, controlled clinical trial in China. The investigators will assess the hypothesis that a 30-days rivaroxaban regimen is superior to aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event.
The TRACE study is a randomized, double-blind clinical trial with a target enrollment of 3,700 Chinese patients. Two subtypes of patients will be enrolled: I, acute disabling ischemic stroke (\<24 hours of symptoms onset); II, acute TIA (\<24 hours of symptoms onset). Patients will be randomized into 3 groups: * Receiving a 100-mg dose of aspirin and placebo rivaroxaban from day 1 to day 30 * Receiving a 5-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30 * Receiving a 10-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30 The primary efficacy end point is percentage of patients with new stroke (ischemic or hemorrhage) at 90 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3,700
orally active direct factor Xa inhibitor
non-steroidal anti-inflammatory drugs
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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