Efficacy and safety of Y-2 sublingual tablet for patients with acute ischaemic stroke: protocol of a phase III randomised double-blind placebo-controlled multicentre trial.

IF 4.4 1区 医学 Q1 CLINICAL NEUROLOGY Stroke and Vascular Neurology Pub Date : 2024-02-27 DOI:10.1136/svn-2022-002014
Yu Fu, Renhong Tang, Rong Chen, Anxin Wang, Jinsheng Ren, Shunwei Zhu, Xiaofei Feng, Dongsheng Fan
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Abstract

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.

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Y-2 舌下含片对急性缺血性中风患者的疗效和安全性: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-右旋倍他诺可以改善急性缺血性脑卒中(AIS)患者的功能预后。本临床试验旨在检测 Y-2 舌下含片对急性缺血性中风(AIS)患者 90 天功能预后的有效性和安全性:这是一项随机、双盲、安慰剂对照、多中心、平行组试验。来自 40 家医院的约 914 名 18-80 岁的 AIS 患者将在症状出现后 48 小时内被随机分配接受 Y-2 舌下含片或安慰剂治疗 14 天。患者在美国国立卫生研究院卒中量表(NIHSS)上的评分为6-20分,且在此次卒中前改良Rankin量表(mRS)≤1,机械血栓切除术和神经保护剂治疗除外:主要研究结果是随机分组后第90天mRS≤1的患者比例。次要疗效结果包括第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天、第30天和第90天NIHSS评分≤1的患者比例:该试验将为Y-2舌下含片改善AIS患者90天功能预后的有效性和安全性提供有价值的证据:试验注册号:NCT04950920。
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来源期刊
Stroke and Vascular Neurology
Stroke and Vascular Neurology Medicine-Cardiology and Cardiovascular Medicine
CiteScore
11.20
自引率
1.70%
发文量
63
审稿时长
15 weeks
期刊介绍: Stroke and Vascular Neurology (SVN) is the official journal of the Chinese Stroke Association. Supported by a team of renowned Editors, and fully Open Access, the journal encourages debate on controversial techniques, issues on health policy and social medicine.
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