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  

作　　者：Yu Fu Renhong Tang Rong Chen Anxin Wang Jinsheng Ren Shunwei Zhu Xiaofei Feng Dongsheng Fan 

机构地区：[1]Deparment of Neurology,Peking University Third Hospital,Beijing,China [2]State Key Laboratory of Neurology and Oncology Drug Development,Nanjing,Jiangsu,China [3]Simcere Pharmaceutical Group Limited,Nanjing,Jiangsu,China [4]Neurodawn Pharmaceutical Co.,Ltd,Nanjing,Jiangsu,China [5]Department of Neurology,Beijing Tiantan Hospital,Capital Medical University,Beijing,China [6]China National Clinical Research Center for Neurological Diseases,Beijing Tiantan Hospital,Capital Medical University,Beijing,China

出　　处：《Stroke & Vascular Neurology》2024年第1期90-95,共6页卒中与血管神经病学（英文）

基　　金：sponsored and funded by Jiangsu Simcere Pharmaceutical(No.SIM1911);National Key R&D Program of China(Grant No.2022YFA1303000).

摘　　要：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.

关 键 词：PATIENTS protective centre 

分 类 号：R743.3[医药卫生—神经病学与精神病学]