Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke. A recent trial indicated that clopidogrel and aspirin treatment reduced the risk of recurrent stroke and was not associated with increased hemorrhage events, compared with aspirin monotherapy. Apixaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants with less risk of bleeding events. To estimate whether apixaban is beneficial for acute TIA or minor stroke, a randomized, double-blind, multicenter, controlled clinical trial has been designed. The investigators will assess the hypothesis that a 21-days apixaban regimen is superior to clopidogrel and aspirin dual-therapy for the treatment of high-risk patients with acute nondisabling cerebrovascular event.
The ADANCE study is a randomized, double-blind clinical trial with a target enrollment of 3,000 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: Ⅰ Receiving a 75 mg dose of clopidogrel and 75mg dose of aspirin from day 1 to day 21, with placebo apixaban twice daily. Ⅱ Receiving a 2.5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21. Ⅲ Receiving a 5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21. From day 22 to 3 months, all patients will receive 75-mg dose of clopidogrel long-term antiplatelet therapy. 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
10,000
orally active direct factor Xa inhibitor
an irreversible inhibitor of the P2Y12 adenosine diphosphate receptor
a non-steroidal anti-inflammatory drug
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
Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
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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