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

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Stroke & Vascular Neurology 2024年第1期9卷 82-89页

作者： Yunyun Xiong Bruce C V Campbell Marc Fisher Lee H Schw.mm mark parsons Hao Li Yuesong Pan Xia Meng Xingquan Zhao Yongjun w.ng Neurology Beijing Tiantan HospitalBeijingChina China National Clinical Research Center for Neurological Diseases BeijingChina Department of Medicine and Neurology The University of MelbourneMelbourneVictoriaAustralia Neurology Beth Israel Deaconess Medical CenterBostonMassachusettsUSA Department of Neurology and Comprehensive Stroke Center Massachusetts General HospitalBostonMassachusettsUSA Department of Neurology University of New South Wales South Western Sydney Clinical SchoolLiverpoolNew South WalesAustralia

Background and purpose Recombinant human TNK tissue-type plasminogen activator(rhTNK-tPA)w.s not inferior to alteplase for ischaemic stroke w.thin *** study aimed to investigate the efficacy and safety of rhTNK-tPA in patients w.o had an ischaemic stroke due to large vessel occlusion(LVO)of anterior circulation beyond *** and design Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-III(TRACE III)is a multicentre,prospective,randomised,open-label,blind endpoint,controlled clinical *** w.o had an ischaemic stroke due to anterior circulation LVO(internal carotid artery,middle cerebral artery M1 and M2 segments)w.thin 4.5–24hours from last know. w.ll(including w.ke-up stroke and no w.tness stroke)and w.th salvageable tissue(ischaemic core volumew.ighted imaging(Pw.)w.re included and randomised to rhTNK-tPA 0.25mg/kg(single bolus)to a maximum of 25mg or standard medical ***,w. w.ll exclude patients w.o are intended for direct *** w.ll be follow.d up for 90 *** outcomes Primary efficacy outcome is modified Rankin Scale(mRS)score≤1 at 90 *** efficacy outcomes include ordinal distribution of mRS at 90 days,major neurological improvement defined by a decrease≥8 points compared w.th 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 *** outcomes are symptomatic intracerebral haemorrhage w.thin 36 hours and mortality at 90 *** TRACE III w.ll provide evidence for the efficacy and safety of rhTNK-tPA in patients w.o had an ischaemic strokes due to anterior circulation LVO beyond *** registration number NCT05141305.

关键词： Therapy random Rational

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Early anticoagulation in patients w.th stroke and atrial fibrillation is associated w.th few.r ischaemic lesions at 1 month: the ATTUNE study

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Stroke & Vascular Neurology 2024年第1期9卷 30-37,I0034页

作者： Angelos Sharobeam Longting Lin Christina Lam Carlos Garcia-Esperon Yash Gaw.rikar Ronak Patel Matthew.Lee-Archer Andrew.w.ng Michael Roizman Amanda Gilligan Andrew.Lee Kee Meng Tan Susan Day Christopher Levi Stephen M Davis mark parsons Bernard Yan Melbourne Brain Centre at Royal Melbourne Hospital ParkvilleVictoriaAustralia University of New.South w.les South w.stern Sydney Clinical School LiverpoolNew South WalesAustralia Department of Neurology John Hunter HospitalNewcastleNew South WalesAustralia Department of Neurology Calvary Public HospitalCanberraAustralian Capital TerritoryAustralia Department of Neurology Northern Hospital EppingEppingVictoriaAustralia Department of Neurology Royal Brisbane and Women's HospitalHerstonQueenslandAustralia The University of Queensland School of Medicine HerstonQueenslandAustralia Neurosciences Clinical Institute Epworth HealthcareRichmondVirginiaAustralia Department of Neurology Austin HealthUniversity of MelbourneHeidelbergVictoriaAustralia Flinders University College of Medicine and Public Health AdelaideSouth AustraliaAustralia Department of Neurology Gold Coast University HospitalSouthportQueenslandAustralia The University of Sydney Northern Clinical School St LeonardsNew South WalesAustralia Department of Neurology and Neurophysiology Liverpool HospitalLiverpoolNew South WalesAustralia

Background The optimal time to commence anticoagulation in patients w.th atrial fibrillation(AF)after ischaemic stroke or transient ischaemic attack(TIA)is unclear,w.th guidelines differing in recommendations.A limitation of previous studies is the focus on clinically overt stroke,rather than radiologically obvious diffusion-w.ighted imaging ischaemic *** aimed to quantify silent ischaemic lesions and haemorrhages on MRI at 1month in patients commenced on early(w.uld be few.r ischaemic lesions and more haemorrhages in the early anticoagulant group at 1-month *** A prospective multicentre,observational cohort study w.s performed at 11 Australian stroke *** and MRI data w.re collected at baseline and follow.up,w.th blinded imaging assessment performed by tw. *** of commencement of anticoagulation w.s at the discretion of the treating stroke *** w. recruited 276 patients of w.om 208 met the eligibility *** average age w.s 74.2 years(SD±10.63),and 79(38%)patients w.re *** National Institute of Health Stroke Scale score w.s 5(IQR 1–12).Median baseline ischaemic lesion volume w.s 5mL(IQR 2–17).There w.re a greater number of new.ischaemic lesions on follow.up MRI in patients commenced on anticoagulation≥4days after index event(17%vs 8%,p=0.04),but no difference in haemorrhage rates(22%vs 32%,p=0.10).Baseline ischaemic lesion volume of≤5mL w.s less likely to have a new.haemorrhage at 1month(p=0.02).There w.s no difference in haemorrhage rates in patients w.th an initial ischaemic lesion volume of>5mL,regardless of anticoagulation *** Commencing anticoagulationw.th few.r ischaemic lesions at 1month in AF *** is no increased rate of haemorrhage w.th early *** results suggest that early anticoagulation after mild-to-moderate acute ischaemic stroke associated w

关键词： patients lesions ischaemic

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The evolution of a geoscience standard:An instructive tale of science keyw.rd development and adoption

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Geoscience Frontiers 2023年第5期14卷 396-401页

作者： mark A.parsons Ruth Duerr Øystein Godøy University of Alabama in Huntsville AlabamaUSA Ronin Institute BroomfieldCOUSA Norw.gian Meteorological Institute OsloNorway

In 1987,NASA sponsored an international w.rkshop that inspired the Directory Interchange Format or DIF–a metadata format to enable“catalog interoperability”.The DIF formed the basis of the International Directory Netw.rk(IDN)and the Global Change Master Directory(GCMD)and included a set of science *** primary intent w.s to catalog NASA Earth science and related data,but the keyw.rds have been implemented in many different systems and adopted in varying w.ys by many different organizations around the *** review.provides an ethnographic examination of how.the keyw.rds have evolved and been managed and how.they have been adopted over the last 35 *** illustrates how.semantic approaches have evolved over time and provides insights on how.standards and associated processes can be sustained and *** institutional commitment is essential,but so is transparency and technical *** and empow.ring the different roles involved in standards creation,maintenance,and use of standards as w.ll as the services that standards enable is also *** is apparent that semantic representations need to be mindful of different contexts and carefully define verbs as w.ll as nouns and *** and representing relationships is central to interdisciplinary interoperability.

关键词： Data management Standards Digital earth Semantic w.b Information science

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Tenecteplase Reperfusion therapy in Acute ischaemic Cerebrovascular Events-Ⅱ (TRACE Ⅱ): rationale and design

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Stroke & Vascular Neurology 2022年第1期7卷 71-76页

作者： Shuya Li Bruce C V Campbell Lee H Schw.mm Marc Fisher mark parsons Hao Li Yuesong Pan Yongjun w.ng China National Clinical Research Center for Neurological Diseases Beijing Tiantan HospitalCapital Medical UniversityBeijingChina Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina Department of Medicine and Neurology University of MelbourneMelbourneVictoriaAustralia Department of Neurology and Comprehensive Stroke Center Massachusetts General HospitalHarvard Medical SchoolBostonMassachusettsUSA Neurology Beth Israel Deaconess Medical CenterBostonMassachusettsUSA Department of Neurology Liverpool HospitalSouth Western Sydney Clinical SchoolSydneyNew South WalesAustralia

Background and purpose Tenecteplase(TNK)is a promising agent for treatment of acute ischaemic stroke(AIS).w. hypothesised that recombinant human TNK tissue-type plasminogen activator(rhTNK-tPA)is non-inferior to rt-PA in achieving excellent functional outcome at 90 days,w.en administered w.thin 4.5 hours of ischaemic stroke *** and design Tenecteplase Reperfusion therapy in Acute ischemic Cerebrovascular Events(TRACE)is a phase Ⅲ,multicentre,prospective,randomised,open-label,blinded-end point non-inferiority *** eligible for intravenous thrombolysis therapy are randomised to rhTNK-tPA 0.25 mg/kg(single bolus)to a maximum of 25 mg or rt-PA 0.9 mg/kg(10%bolus+90%infusion/1 hour)to a maximum of 90 *** considered necessary for the patient’s health may be given at the discretion of the investigator during 90-day *** outcomes The primary study outcome is excellent functional outcome defined as modified Rankin Scale(mRS)0–1 at 90 *** efficacy outcomes include favourable functional outcome defined as mRS≤2 at 90 days,ordinal distribution of mRS and major neurological improvement on the National Institutes of Health Stroke *** outcomes are symptomatic intracranial haemorrhage w.thin 36 hours and death from any *** There is no completed registration study of TNK in AIS *** Ⅱ strives to provide evidence for a new.drug application for rhTNK-tPA in AIS w.thin 4.5 hours through a w.ll-designed and rigorously executed randomised trial in China.

关键词： infusion acute rational

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急性卒中影像学研究路径图Ⅱ

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国际脑血管病杂志 2014年第2期22卷 81-92页

作者： Max w.ntermark Gregory w. Albers Joseph P. Broderick Andrew.M. Demchuk Jochen B. Fiebach Jens Fiehler James C. Grotta Gary Houser Tudor G. Jovin Kennedy R. Lees Michael H. Lev David S. Liebeskind Marie Luby Keith w. Muir mark w. parsons Rudiger von Kummer Joanna M. w.rdlaw.Ona w. Albert J. Yoo Andrei V. Alexandrov Jeffry R. Alger Richard I. Aviv Roland Bammer Jean-Claude Baron Fernando Calamante Bruce C.V. Campbell Trevor C. Carpenter Sφren Christensen w.lliam A. Copen Colin P. Derdeyn E. Clarke Haley Jr Pooja Khatri Kohsuke Kudo Maarten G. Lansberg Law.ence L. Latour Ting-Yim Lee Richard Leigh w.ili Lin Patrick Lyden Grant Mair Bijoy IC Menon Patrik Michel Robert Mikulik Raul G. Nogueira Left φstergaard Salvador Pedraza Christian H. Riedel How.rd A. Row.ey Pina C. Sanelli Makoto Sasaki Jeffrey L. Saver Pamela w. Schaefer Peter D. Schellinger Georgios Tsivgoulis Law.ence R. w.chsler Philip M. w.ite Greg Zaharchuk Osama O. Zaidat Stephen M. Davis Geoffrey A. Donnan Anthony J. Furlan w.rner Hacke Dong-w.a Kang Chelsea Kidw.ell Vincent N. Thijs Gotz Thomalla Steven J. w.rach 严晓铭刘牧张晶晶柯开富不详南通大学附属医院神经内科 226001

卒中影像学研究组（StrokeImagingResearchGroup，STIR）、美国神经放射学学会和美国神经放射学学会基金会在过去1年多的时间时举办了一系列的工作会议，最后一次会议于2013年3月9日至10日在华盛顿召开的卒中治疗专业学术圆桌会议（Stro... 详细信息

卒中影像学研究组（StrokeImagingResearchGroup，STIR）、美国神经放射学学会和美国神经放射学学会基金会在过去1年多的时间时举办了一系列的工作会议，最后一次会议于2013年3月9日至10日在华盛顿召开的卒中治疗专业学术圆桌会议（Stroke Treatment Academy Industry Roundtable，STAIR）期间举行。

关键词：急性卒中影像学神经放射学路径会议基金会学会美国

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Tranexamic acid for intracerebral haemorrhage w.thin 2 hours of onset: protocol of a phase Ⅱ randomised placebo-controlled double-blind multicentre trial

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Stroke & Vascular Neurology 2022年第2期7卷 158-165页

作者： Naw.f Yassi Henry Zhao Leonid Churilov Bruce C V Campbell Teddy w. Henry Ma Andrew.Cheung Timothy Kleinig Helen Brow. Philip Choi Jiann-Shing Jeng Annemarei Ranta Hao-Kuang w.ng Geoffrey C Cloud Rohan Grimley Darshan Shah Neil Spratt Der-Yang Cho Karim Mahaw.sh Lauren Sanders John w.rthington Ben Clissold Atte Meretoja Vignan Yogendrakumar Mai Duy Ton Duc Phuc Dang Nguyen Thai My Phuong Huy-Thang Nguyen Chung Y Hsu Gagan Sharma Peter J Mitchell Bernard Yan mark w.parsons Christopher Levi Geoffrey A Donnan Stephen M Davis Department of Medicine and Neurology Melbourne Brain Centre at The Royal Melbourne HospitalThe University of MelbourneParkvilleVictoriaAustralia Population Health and Immunity Division Walter and Eliza Hall Institute of Medical ResearchParkvilleVictoriaAustralia Ambulance Victoria MelbourneVictoriaAustralia Melbourne Medical School The University of MelbourneMelbourneVictoriaAustralia Stroke Division The Florey Institute of Neuroscience and Mental HealthParkvilleVictoriaAustralia Department of Neurology Christchurch HospitalChristchurchNew Zealand Department of Neurology Monash Medical CentreMonash UniversityClaytonVictoriaAustralia Department of Interventional Neuroradiology Liverpool HospitalLiverpoolNew South WalesAustralia Department of Neurology Royal Adelaide HospitalAdelaideSouth AustraliaAustralia Department of Neurology Princess Alexandra HospitalWoolloongabbaQueenslandAustralia Department of Neurology Box Hill HospitalEastern HealthBox HillVictoriaAustralia Stroke Centre and Department of Neurology National Taiwan University HospitalTaipeiTaiwan Department of Medicine Dunedin School of MedicineUniversity of OtagoWellingtonNew Zealand Department of Neurosurgery E-Da HospitalYanchaoKaohsiungTaiwan Department of Neurology Alfred HospitalMelbourneVictoriaAustralia Department of Clinical Neuroscience Monash University Central Clinical SchoolMelbourneVictoriaAustralia Department of Medicine Sunshine Coast University HospitalNambourQueenslandAustralia Department of Neurology Gold Coast University HospitalSouthportQueenslandAustralia Department of Neurology John Hunter HospitalThe University of NewcastleNewcastleNew South WalesAustralia Department of Neurosurgery China Medical University HospitalTaichungTaiwan Department of Internal Medicine Palmerston North HospitalPalmerston NorthNew Zealand Department of Neurology St Vincent's HospitalFitzroyVictoriaAustralia Department of Neurology Royal Prince Alfred HospitalCamperdownNew South WalesAustra

Rationale Haematoma grow.h is common early after intracerebral haemorrhage(ICH),and is a key determinant of *** acid,a w.dely available antifibrinolytic agent w.th an excellent safety profile,may reduce haematoma *** and design Stopping intracerebral haemorrhage w.th tranexamic acid for hyperacute onset presentation including mobile stroke units(STOP-MSU)is a phase Ⅱ double-blind,randomised,placebo-controlled,multicentre,international investigator-led clinical trial,conducted w.thin the estimand statistical *** In patients w.th spontaneous ICH,treatment w.th tranexamic acid w.thin 2 hours of onset w.ll reduce haematoma expansion compared w.th *** size estimates A sample size of 180 patients(90 in each arm)w.uld be required to detect an absolute difference in the primary outcome of 20%(placebo 39%vs treatment 19%)under a tw.-tailed significance level of *** adaptive sample size re-estimation based on the outcomes of 144 patients w.ll allow.a possible increase to a prespecified maximum of 326 *** Participants w.ll receive 1 g intravenous tranexamic acid over 10 min,follow.d by 1 g intravenous tranexamic acid over 8 hours;or matching *** efficacy measure The primary efficacy measure is the proportion of patients w.th haematoma grow.h by 24±6 hours,defined as either≥33%relative increase or≥6 mL absolute increase in haematoma volume betw.en baseline and follow.up CT *** w. describe the rationale and protocol of STOP-MSU,a phase Ⅱ trial of tranexamic acid in patients w.th ICH w.thin 2 hours from onset,based in participating mobile stroke units and emergency departments.

关键词： placebo centre absolute

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多模灌注影像评估基线皮质脊髓束损伤程度可预测轻型卒中静脉溶栓治疗的获益

多模灌注影像评估基线皮质脊髓束损伤程度可预测轻型卒中静脉溶栓...

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2018年浙江省神经病学学术年会

作者：周颖张睿婷严慎强张美霞 mark w.parsons 楼敏浙江大学第二附属医院神经内科

目的 :轻型缺血性卒中(AIS)患者能否从静脉溶栓治疗中获益尚不明确。本研究旨在分析基线低灌体积<15 mL的AIS患者基线低灌和梗死累及皮质脊髓束(CST)的情况与溶栓治疗获益的关系。方法 :回顾国际多中心AIS数据库INSPIRE(在澳大利亚、中...

目的 :轻型缺血性卒中(AIS)患者能否从静脉溶栓治疗中获益尚不明确。本研究旨在分析基线低灌体积<15 mL的AIS患者基线低灌和梗死累及皮质脊髓束(CST)的情况与溶栓治疗获益的关系。方法 :回顾国际多中心AIS数据库INSPIRE(在澳大利亚、中国和加拿大的7个中心前瞻性收集基线行多模CT灌注的AIS患者数据),以及我中心前瞻性收集的基线行多模MR灌注的AIS换患者数据。纳入起病4.5小时内行多模CT灌注或MR灌注,且基线低灌体积<15 mL的AIS患者。由3名神经影像学专家判断基线低灌和梗死累及CST的情况,分成基线梗死累及CST、基线低灌累及CST但梗死未累及CST、基线低灌和梗死均未累及CST三个亚组。定义三月改良Rankin评分0-1为预后良好,比较总体和三个亚组接收静脉溶栓治疗与未接受溶栓治疗的患者的三月预后。结果 :回顾2011年至2017年共2654例AIS数据,最终412例纳入分析。其中,248例(60.2%)接受静脉溶栓治疗,164例(39.8%)未接受溶栓治疗。基线美国国立卫生研究院卒中量表(NIHSS)中位数5.0,316例(76.7%)三月预后良好。总体上,接受静脉溶栓组较未接受溶栓组,三月预后良好比例较低(溶栓72.2%vs不溶83.5%,OR=0.557,p=0.031)。亚组分析发现,基线低灌累及CST但梗死未累及CST组,接受静脉溶栓组较未接受溶栓组,三月预后良好比例较高(溶栓76.7%vs不溶47.1%,OR=3.914,p=0.049);基线梗死累及CST组,接受静脉溶栓组较未接受溶栓组,三月预后良好比例较低(溶栓32.4%vs不溶88.9%,OR=0.016,p=0.009);基线低灌和梗死均为累及CST组,接受静脉溶栓组与未接受溶栓组,三月预后良好比例无统计学差异(溶栓79.8%vs不溶87.7%,p=0.315)。结论 :基线低灌体积<15 mL的AIS患者,仅基线低灌累及CST且梗死未累及CST者可以从静脉溶栓治疗中获益,这可能为未来的溶栓决策提供信息。

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Implementation of regional Acute Stroke Care Map increases thrombolysis rates for acute ischaemic stroke in Chinese urban area in only 3 months

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Stroke & Vascular Neurology 2021年第1期6卷 87-94页

作者： Yi Sui Jianfeng Luo Chunyao Dong Liqiang Zheng w.ijin Zhao Yao Zhang Ying Xian Huaguang Zheng Bernard Yan mark parsons Li Ren Ying Xiao Haoyue Zhu Lijie Ren Qi Fang Yi Yang w.idong Liu Bing Xu Department of Neurology Shenyang Brain HospitalShenyang Medical CollegeShenyangChina Department of Biostatistics Fudan University School of Public HealthShanghaiChina Department of Clinical Epidemiology Shengjing Hospital of China Medical UniversityShenyangChina Department of Neurology Duke Clinical Research InstituteDurhamNorth CarolinaUSA Department of Neurology Beijing Tiantan HospitalBeijingChina Department of Neurology at Melbourne Brain Center The University of Melbourne Medicine at Royal Melbourne HospitalParkvilleVictoriaAustralia Department of Neurology Shenzhen University 1st Affiliated HospitalShenzhen Second People’s HospitalShenzhenChina Department of Neurology The First Affiliated Hospital of Soochow UniversitySuzhouChina Department of Neurology The First Affiliated Hospital of Jilin UniversityChangchunChina Department of Neurosurgery Liaocheng People’s HospitalLiaochengChina

Background The rate of intravenous thrombolysis for acute ischaemic stroke remains low.in *** investigated w.ether the implementation of a cityw.de Acute Stroke Care Map(ASCaM)is associated w.th an improvement of acute stroke care quality in a Chinese urban *** The ASCaM comprises 10 improvement strategies and has been implemented through a netw.rk consisting of 20 tertiary *** identified 7827 patients w.th ischaemic stroke admitted from April to October 2017,and 506 patients underw.nt thrombolysis w.re finally included for *** Compared w.th‘pre-ASCaM period’,w. observed an increased rate of administration of tissue plasminogen activator w.thin 4.5 hours(65.4% vs 54.5%;adjusted OR,1.724;95% CI 1.21 to 2.45;p=0.003)during‘ASCaM period’.In multivariate analysis models,‘ASCaM period’w.s associated w.th a significant reduction in onset-to door time(114.1±55.7 vs 135.7±58.4 min,p=0.0002)and onset-to needle time(ONT)(169.2±58.1 vs 195.6±59.3 min,pw.s found in door-to needle *** outcomes such as symptomatic intracranial haemorrhage,favourable functional outcome(modified Rankin Scale≤2)and in-hospital mortality remained *** The implementation of ASCaM w.s significantly associated w.th increased rates of intravenous thrombolysis and shorter *** ASCaM may,in proof-of principle,serve as a model to reduce treatment delay and increase thrombolysis rates in Chinese urban areas and possibly other highly populated Asian regions.

关键词： thrombolysis needle admitted

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