Background Acute ischaemic stroke,due to its high mortality and disability rates,imposes a significant economic and social burden worldwide.Typically,endovascular treatment within the therapeutic window is provided to...Background Acute ischaemic stroke,due to its high mortality and disability rates,imposes a significant economic and social burden worldwide.Typically,endovascular treatment within the therapeutic window is provided to salvage the ischaemic penumbra;however,even when recanalisation is successful during endovascular treatment,the clinical outcomes may still be disappointing.This highlights the necessity of further research,so as to discover better solutions to futile recanalisation and improve patient outcomes.Objective To investigate the efficacy and safety of Y-6 sublingual tablets(cilostazol and dexborneol)compared with a placebo in the treatment of patients with acute ischaemic stroke caused by large vessel occlusion.Method The efficacy and safety of Y-6 sublingual tablets in patients with acute ischaemic stroke are evaluated in a phase Ⅱ,randomised,double-blind,double-dummy,placebo-controlled,parallel clinical trial.Eligible patients having provided informed consent are randomised into five groups for a 28-day treatment period.The primary outcome is the percentage of patients achieving the modified Rankin Scale score of 0-1 at 90 days.Discussion The EFfects of Y-6 SUblingual Tablets for PaTients with AcUte Ischemic StRokE trial assesses whether Y-6 sublingual tablets are effective and safe in improving the clinical outcomes of patients with acute ischaemic stroke caused by large vessel occlusion.展开更多
基金supported by grants from the National Natural Science Foundation of China(No.82425101)Beijing Municipal Science&Technology Commission(No.Z231100004823036)+8 种基金Capital's Funds for Health Improvement and Research(2022-2-2045)National Key R&D Program of China(2024YFC3044800,2022YFF1501500,2022YFF1501501,2022YFF1501502,2022YFF1501503,2022YFF1501504,2022YFF1501505)Youth Beijing Scholar Program(No.010)Beijing Laboratory of Oral Health(PXM2021_014226_000041)Beijing Talent Project-Class A:Innovation and Development(No.2018A12)National Ten-Thousand Talent Plan"-Leadership of Scientific and Technological InnovationNational Key R&D Program of China(No.2017YFC1307900,2017YFC1307905)Beijing Outstanding Young Scientist Program(No.BJJWZYJH01201910025030)Noncommunicable Chronic Diseases-National Science and Technology Major Project(2023ZD0504800,2023ZD0504801,2023ZD0504802,2023ZD0504803,2023ZD0504804)。
文摘Background Acute ischaemic stroke,due to its high mortality and disability rates,imposes a significant economic and social burden worldwide.Typically,endovascular treatment within the therapeutic window is provided to salvage the ischaemic penumbra;however,even when recanalisation is successful during endovascular treatment,the clinical outcomes may still be disappointing.This highlights the necessity of further research,so as to discover better solutions to futile recanalisation and improve patient outcomes.Objective To investigate the efficacy and safety of Y-6 sublingual tablets(cilostazol and dexborneol)compared with a placebo in the treatment of patients with acute ischaemic stroke caused by large vessel occlusion.Method The efficacy and safety of Y-6 sublingual tablets in patients with acute ischaemic stroke are evaluated in a phase Ⅱ,randomised,double-blind,double-dummy,placebo-controlled,parallel clinical trial.Eligible patients having provided informed consent are randomised into five groups for a 28-day treatment period.The primary outcome is the percentage of patients achieving the modified Rankin Scale score of 0-1 at 90 days.Discussion The EFfects of Y-6 SUblingual Tablets for PaTients with AcUte Ischemic StRokE trial assesses whether Y-6 sublingual tablets are effective and safe in improving the clinical outcomes of patients with acute ischaemic stroke caused by large vessel occlusion.
