Antiplatelet vs. R-tPA for acute mild ischemic stroke: A prospective, random, and open label multi-center study.,International Journal of Stroke

当前位置： X-MOL 学术 › Int. J. Stroke › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

Antiplatelet vs. R-tPA for acute mild ischemic stroke: A prospective, random, and open label multi-center study.
International Journal of Stroke ( IF 6.7 ) Pub Date : 2019-03-25 , DOI: 10.1177/1747493019832998
Xin-Hong Wang ₁ , Lin Tao ₁ , Zhong-He Zhou ₁ , Xiao-Qiu Li ₁ , Hui-Sheng Chen ₁

Affiliation

RATIONALE The evidence of intravenous thrombolysis in patients with not clearly disabling minor stroke (low National Institutes of Health Stroke Scale of 0-5) is still insufficient. Recent early terminated PRISMS trial could not provide definitive conclusion, although suggesting the similar functional outcome between alteplase and aspirin groups. Recent two clinical trials provide a definitive evidence for the superiority of dual antiplatelet to mono-antiplatelet in minor stroke. However, the efficacy and safety of dual antiplatelet vs. alteplase in the treatment of acute minor stroke are not known. AIM To explore the efficacy and safety of dual antiplatelet with aspirin and clopidogrel vs. alteplase in the treatment of acute minor stroke. SAMPLE SIZE ESTIMATES A maximum of 760 subjects are required to test the non-inferiority hypothesis with 80% power according to a one-sided 0.025 level of significance, stratified by age, diabetes, time from onset to treatment, stroke etiology, degree of vascular stenosis, location of index vessel. METHODS AND DESIGN ARAMIS is a prospective, randomized, open label, blinded assessment of endpoints (PROBE) and multicenter clinical trial in China. The subjects are randomized to the control arm (intravenous alteplase with standard dose of 0.9 mg/kg, followed by guideline-based treatment 24 h after thrombolysis) or the experiment arm (clopidogrel: loading dose of 300 mg on the first day, followed by 75 mg daily for 10-14 days; aspirin: 100 mg on the first day, followed by 100 mg daily for 10-14 days; after the combination, antiplatelet will be given based on guideline till 90 days). STUDY OUTCOME The primary efficacy endpoint is favorable functional outcome, defined as a mRS 0-1 assessed at 90-day post-randomization.

更新日期：2019-03-25

点击分享查看原文

点击收藏

阅读更多本刊最新论文本刊介绍/投稿指南

全部期刊列表>>