Background and purpose Clinical studies have demonstrated that edaravone dexborneol can improve the functional outcomes in patients with acute ischaemic stroke (AIS). The present clinical trial aimed at testing the efficacy and safety of Y-2 sublingual tablet on 90-day functional outcome in patients with AIS. Methods and design This is a randomised, double-blind, placebo-controlled, multicentre, parallel-group trial of Y-2 sublingual tablet on patients with AIS. An estimated 914 patients at age of 18–80 years with AIS within 48 hours after symptom onset from 40 hospitals will be randomly assigned to receive Y-2 sublingual tablet or placebo for 14 days. Patients are at score 6–20 points on National Institutes of Health Stroke Scale (NIHSS) and had a modified Rankin Scale (mRS) ≤1 before this stroke, except mechanical thrombectomy and neuroprotective agents treatment. Study outcomes The primary outcome is the proportion of patients with mRS ≤1 on day 90 after randomisation. Secondary efficacy outcomes include mRS score on day 90, the proportion of patients with mRS ≤2 on day 90; the change of NIHSS score from baseline to day 14 and the proportion of patients with NIHSS score ≤1 at the days 14, 30 and 90. Discussion This trial will provide valuable evidence for the efficacy and safety of Y-2 sublingual table for improving 90 days the functional outcomes in patients with AIS. Trial registration number [NCT04950920][1]. Data are available on reasonable request. No data are available. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04950920&atom=%2Fsvnbmj%2F9%2F1%2F90.atom

中文翻译：

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Y-2舌下含片治疗急性缺血性脑卒中的疗效和安全性：III期随机双盲安慰剂对照多中心试验方案

背景和目的临床研究表明依达拉奉右冰片可以改善急性缺血性脑卒中（AIS）患者的功能结果。本临床试验旨在测试 Y-2 舌下含片对 AIS 患者 90 天功能结果的有效性和安全性。方法和设计 这是一项针对 AIS 患者使用 Y-2 舌下含片进行的随机、双盲、安慰剂对照、多中心、平行组试验。来自 40 家医院的估计 914 名 18-80 岁、症状出现后 48 小时内患有 AIS 的患者将被随机分配接受 Y-2 舌下含片或安慰剂治疗，为期 14 天。患者在美国国立卫生研究院卒中量表 (NIHSS) 上得分为 6-20 分，并且在此次卒中之前，改良兰金量表 (mRS) ≤1，机械血栓切除术和神经保护剂治疗除外。研究结果 主要结果是随机分组后第 90 天 mRS ≤1 的患者比例。次要疗效结局包括第90天的mRS评分、第90天mRS≤2的患者比例；NIHSS评分从基线到第14天的变化以及第14、30和90天NIHSS评分≤1的患者比例。讨论本试验将为Y-2舌下含服表改善90的有效性和安全性提供有价值的证据天 AIS 患者的功能结果。试用注册号[NCT04950920][1]。可根据合理要求提供数据。无可用数据。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04950920&atom=%2Fsvnbmj%2F9%2F1%2F90.atom