Tenecteplase thrombolysis for stroke up to 24 hours after onset with perfusion imaging selection:the umbrella phase IIa CHABLIS-T randomised clinical trial  

作　　者：Xin Cheng Lan Hong Leonid Churilov Longting Lin Yifeng Ling Jin Zhang Jianhong Yang Yu Geng Danhong Wu Xueyuan Liu Xiaoyu Zhou Yuwu Zhao Qijin Zhai Liandong Zhao Yangmei Chen Ying Guo Xiaofei Yu Fan Gong Yi Sui Gang Li Lumeng Yang Hong-Qiu Gu Yilong Wang Mark Parsons Qiang Dong the CHABLIS-T collaborators 

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]Melbourne Medical School,The Royal Melbourne Hospital,University of Melbourne,Parkville,Victoria,Australia [3]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 [4]Department of Neurology,the First Hospital of Shanxi Medical University,Taiyuan,China [5]Department of Neurology,Ningbo First Hospital,Ningbo,China [6]Center for Rehabilitation Medicine,Department of Neurology,Zhejiang Provincial People’s Hospital(Affiliated People’s Hospital,Hangzhou Medical College),Hangzhou,China [7]Department of Neurology,Shanghai Fifth People's Hospital,Fudan University,Shanghai,China [8]Department of Neurology,Shanghai Tenth People's Hospital,Tongji University School of Medicine,Shanghai,China [9]Department of Neurology,Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai,China [10]Department of Neurology,Xuzhou Medical University Affiliated Hospital of Huaian,Huaian,China [11]Department of Neurology,The Second Affiliated Hospital of Chongqing Medical University,Chongqing,China [12]Department of Neurology,Pu'er People's Hospital,Pu'er,China [13]Department of Neurology,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,China [14]Department of Neurology,Shenyang First People's Hospital,Shenyang Medical College Affiliated Brain Hospital,Shenyang,China [15]Department of Neurology,Shanghai East Hospital,Tongji University,Shanghai,China [16]China National Clinical Research Center for Neurological Diseases,Beijing Tiantan Hospital,Beijing,China [17]Department of Neurology,Beijing Tiantan Hospital,Capital Medical University,Beijing,China [18]不详

出　　处：《Stroke & Vascular Neurology》2024年第5期551-559,共9页卒中与血管神经病学（英文）

基　　金：National Key R&D Program of China(2017YFC1308201);Clinical Research Plan of SHDC(SHDC2020CR1041B);Shanghai Municipal Key Clinical Specialty(shslczdzk06102).

摘　　要：Background The performance of intravenous tenecteplase in patients who had an acute ischaemic stroke with large/medium vessel occlusion or severe stenosis in an extended time window remains unknown. We investigated the promise of efficacy and safety of different doses of tenecteplase manufactured in China, in patients who had an acute ischaemic stroke with large/ medium vessel occlusion beyond 4.5- hour time window. Methods The CHinese Acute tissue- Based imaging selection for Lysis In Stroke- Tenecteplase was an investigator- initiated, umbrella phase IIa, open- label, blinded- endpoint, Simon’s two- stage randomised clinical trial in 13 centres across China's Mainland. Participants who had salvageable brain tissue on automated perfusion imaging and presented within 4.5-24 hours from time of last seen well were randomised to receive 0.25 mg/ kg tenecteplase or 0.32 mg/kg tenecteplase, both with a bolus infusion over 5-10 s. The primary outcome was proportion of patients with promise of efficacy and safety defined as reaching major reperfusion without symptomatic intracranial haemorrhage at 24-48 hours after thrombolysis. Assessors were blinded to treatment allocation. All participants who received tenecteplase were included in the analysis. Results A total of 86 patients who had an acute ischaemic stroke identified with anterior large/medium vessel occlusion or severe stenosis were included in this study from November 2019 to December 2021. All of the 86 patients enrolled either received 0.25 mg/kg (n=43) or 0.32 mg/kg (n=43) tenecteplase, and were available for primary outcome analysis. Fourteen out of 43 patients in the 0.25 mg/kg tenecteplase group and 10 out of 43 patients in the 0.32 mg/kg tenecteplase group reached the primary outcome, providing promise of efficacy and safety for both doses based on Simon’s two- stage design. Discussion Among patients with anterior large/medium vessel occlusion and significant penumbral mismatch presented within 4.5-24 hours from time of last seen well, tenecteplase 0.

关 键 词：doses THROMBOLYSIS random 

分 类 号：R743.3[医药卫生—神经病学与精神病学]