Rationale and design of Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events III (TRACE III): a randomised, phase III, open- label, controlled trial  

作　　者：Yunyun Xiong Bruce C V Campbell Marc Fisher Lee H Schwamm Mark Parsons Hao Li Yuesong Pan Xia Meng Xingquan Zhao Yongjun Wang 

机构地区：[1]Neurology,Beijing Tiantan Hospital,Beijing,China [2]China National Clinical Research Center for Neurological Diseases,Beijing,China [3]Department of Medicine and Neurology,The University of Melbourne,Melbourne,Victoria,Australia [4]Neurology,Beth Israel Deaconess Medical Center,Boston,Massachusetts,USA [5]Department of Neurology and Comprehensive Stroke Center,Massachusetts General Hospital,Boston,Massachusetts,USA [6]Department of Neurology,University of New South Wales South Western Sydney Clinical School,Liverpool,New South Wales,Australia

出　　处：《Stroke & Vascular Neurology》2024年第1期82-89,共8页卒中与血管神经病学（英文）

基　　金：supported by the National Natural Science Foundation of China(81870905,82171272);Beijing Municipal Science&Technology Committee(Z211100003521019);Beijing Hospitals Authority(PX2022019).

摘　　要：Background and purpose Recombinant human TNK tissue-type plasminogen activator(rhTNK-tPA)was not inferior to alteplase for ischaemic stroke within 4.5hours.Our study aimed to investigate the efficacy and safety of rhTNK-tPA in patients who had an ischaemic stroke due to large vessel occlusion(LVO)of anterior circulation beyond 4.5hours.Methods and design Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-III(TRACE III)is a multicentre,prospective,randomised,open-label,blind endpoint,controlled clinical trial.Patients who had an ischaemic stroke due to anterior circulation LVO(internal carotid artery,middle cerebral artery M1 and M2 segments)within 4.5–24hours from last known well(including wake-up stroke and no witness stroke)and with salvageable tissue(ischaemic core volume<70mL,mismatch ratio≥1.8 and mismatch volume≥15mL)based on CT perfusion or MRI perfusion-weighted imaging(PWI)were included and randomised to rhTNK-tPA 0.25mg/kg(single bolus)to a maximum of 25mg or standard medical therapy.Specially,we will exclude patients who are intended for direct thrombectomy.All will be followed up for 90 days.Study outcomes Primary efficacy outcome is modified Rankin Scale(mRS)score≤1 at 90 days.Secondary efficacy outcomes include ordinal distribution of mRS at 90 days,major neurological improvement defined by a decrease≥8 points compared with the initial deficit or a score≤1 on the National Institutes of Health Stroke Scale(NIHSS)at 72 hours,mRS score≤2 at 90 days,the rate of improvement on Tmax>6s at 24 hours and NIHSS score change from baseline at 7days.Safety outcomes are symptomatic intracerebral haemorrhage within 36 hours and mortality at 90 days.Discussion TRACE III will provide evidence for the efficacy and safety of rhTNK-tPA in patients who had an ischaemic strokes due to anterior circulation LVO beyond 4.5hours.Trial registration number NCT05141305.

关 键 词：Therapy random Rational 

分 类 号：R743.3[医药卫生—神经病学与精神病学]