CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke TenecteplaseⅡ(CHABLIS-TⅡ):rationale and design  

作　　者：Xin Cheng Lan Hong Longting Lin Leonid Churilov Yifeng Ling Yiran Zhang Lumeng Yang Mark Parsons Qiang Dong 

机构地区：[1]Department of Neurology,National Center for Neurological Disorders,National Clinical Research Centre for Aging and Medicine,Huashan Hospital,Fudan University,Shanghai,China [2]University of New South Wales South Western Sydney Clinical School,Ingham Institute for Applied Medical Research,Department of Neurology,Liverpool Hospital,Sydney,New South Wales,Australia [3]Melbourne Medical School,The Royal Melbourne Hospital,University of Melbourne,Melbourne,Victoria,Australia

出　　处：《Stroke & Vascular Neurology》2024年第6期708-714,共7页卒中与血管神经病学(英文)

摘　　要：Background and purpose Tenecteplase(TNK)has demonstrated non-inferiority to alteplase in patients who had an acute ischaemic stroke presenting within 4.5 hours from symptom onset.The trial is aimed to explore the efficacy and safety of TNK in Chinese patients who had an acute ischaemic stroke with large/medium vessel occlusion in an extended time window.Methods and design Chinese Acute Tissue-Based Imaging Selection for Lysis In Stroke TenecteplaseⅡ(CHABLIS-TⅡ)is a multicentre,prospective,block-randomised,open-label,blinded-endpoint,phaseⅡb study.Eligible patients are 1:1 randomised into two groups:0.25 mg/kg TNK versus best medical management(excluding TNK).The safety and efficacy of 0.25 mg/kg TNK are assessed through reperfusion status and presence of symptomatic intracranial haemorrhage(sICH).Study outcomes The primary outcome is major reperfusion without sICH at 24–48 hours after randomisation.Major reperfusion is defined as restoration of blood flow to greater than 50%of the involved ischaemic territory assessed by catheter angiography or repeated perfusion imaging.Secondary outcomes include post-thrombolytic recanalisation,neurological improvements,change in the National Institutes of Health Stroke Scale score,haemorrhagic transformation at 24–48 hours,systematic bleeding at discharge,modified Rankin Scale(mRS)0–1,mRS 0–2,mRS 5–6,mRS distribution and Barthel index at 90 days.Discussion CHABLIS-TⅡwill provide important evidence of intravenous thrombolysis with TNK for patients who had an acute stroke in an extended time window.

关 键 词：RATIONAL SELECTION CENTRE 

分 类 号：R743.3[医药卫生—神经病学与精神病学]