Rationale and design of Treatment of Acute Ischaemic Stroke with Edaravone Dexborneol Ⅱ(TASTE-2):a multicentre randomised controlled trial  

作　　者：Chunjuan Wang Hong-Qiu Gu Qiang Dong Anding Xu Ning Wang Yi Yang Feng Wang Yongjun Wang 

机构地区：[1]China National Clinical Research Center for Neurological Diseases,Beijing Tiantan Hospital,Capital Medical University,Beijing,China [2]Department of Neurology,Beijing Tiantan Hospital,Capital Medical University,Beijing,China [3]Department of Neurology,Huashan Hospital,Fudan University,Shanghai,Shanghai,China [4]Department of Neurology,The First Affiliated Hospital of Jinan University,Guangzhou,China [5]Department of Neurology,The First Affiliated Hospital,Institute of Neuroscience,Fujian Medical University,Fuzhou,China [6]Department of Neurology,The First Hospital of Jilin University,Changchun,China [7]State Key Laboratory of Neurology and Oncology Drug Development,Nanjing,China [8]Vascular Neurology,Department of Neurology,Beijing Tiantan Hospital,Beijing,China [9]Chinese Institute for Brain Research,Beijing,China [10]Research Unit of Artificial Intelligence in Cerebrovascular Disease,Chinese Academy of Medical Sciences,Beijing,China

出　　处：《Stroke & Vascular Neurology》2024年第6期730-737,共8页卒中与血管神经病学(英文)

基　　金：Simcere Pharmaceutical Group,the Ministry of Science and Technology of the People’s Republic of China(2022YFC2504902,2022YFC2504904);National Natural Science Foundation of China(81801152,92046016);CAMS Innovation Fund for Medical Sciences(2019-I2M 5-029);Beijing Municipal Committee of Science and Technology(Z201100005620010,Z211100002921064).

摘　　要：Background Edaravone dexborneol is believed to be a novel cytoprotective drug,demonstrating a synergistic combination of antioxidative and anti-inflammatory properties in animal models.The Treatment of Acute Ischaemic Stroke with Edaravone Dexborneol(TASTE)trial demonstrated its superior efficacy over edaravone alone for acute ischaemic stroke(AIS)patients.However,its efficacy in individuals undergoing endovascular therapy(EVT)remains uncertain.Aim To clarify the rationale and design of the TASTE Ⅱ(TASTE-2)trial.Design The TASTE-2 is a multicentre,double-blind,randomised,placebo-controlled trial designed to evaluate the efficacy and safety of edaravone dexborneol in patients with AIS and large-vessel occlusion in the anterior circulation.The eligible participants,presenting with a National Institute of Health Stroke Scale score between 6 and 25(range 0–42,with larger values suggesting severe neurological dysfunction)and an Alberta Stroke Program Early Computed Tomography Score ranging from 6 to 10(range 0–10,with smaller values suggesting larger infarction)within the initial 24 hours after symptom onset,will be randomly allocated to either the edaravone dexborneol group or the placebo group in equal proportions prior to thrombectomy.The treatment will be continuously administered for a duration of 10–14 days.A follow-up period of 90 days will be implemented for all participants.Study outcomes The primary efficacy outcome is defined as achieving favourable functional independence,measured by a modified Rankin Scale of 0–2 at 90 days.The primary safety outcome focuses on the incidence of serious adverse events.Discussion The TASTE-2 trial will provide evidence to determine whether the administration of edaravone dexborneol in AIS patients undergoing EVT could yield significant improvements in neurological function.

关 键 词：protective CENTRE RANDOM 

分 类 号：R743.3[医药卫生—神经病学与精神病学]