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dc.contributor.authorMa, Henry Ken
dc.contributor.authorParsons, Mark Wen
dc.contributor.authorChristensen, Sorenen
dc.contributor.authorCampbell, Bruce C Ven
dc.contributor.authorChurilov, Leoniden
dc.contributor.authorConnelly, Alanen
dc.contributor.authorYan, Bernarden
dc.contributor.authorBladin, Christopheren
dc.contributor.authorPhan, Thanen
dc.contributor.authorBarber, P Alanen
dc.contributor.authorRead, Stephenen
dc.contributor.authorHankey, Graeme Jen
dc.contributor.authorMarkus, Romeshen
dc.contributor.authorWijeratne, Tissaen
dc.contributor.authorGrimley, Ren
dc.contributor.authorMahant, Nen
dc.contributor.authorKleinig, Timen
dc.contributor.authorSturm, Johnen
dc.contributor.authorLee, Aen
dc.contributor.authorBlacker, Den
dc.contributor.authorGerraty, Richarden
dc.contributor.authorKrause, Men
dc.contributor.authorDesmond, Patricia Men
dc.contributor.authorMcBride, S Jen
dc.contributor.authorCarey, Leeanne Men
dc.contributor.authorHowells, David Williamen
dc.contributor.authorHsu, C Yen
dc.contributor.authorDavis, Stephen Men
dc.contributor.authorDonnan, Geoffrey Aen
dc.identifier.citationInternational Journal of Stroke : Official Journal of the International Stroke Society; 7(1): 74-80en
dc.description.abstractThrombolytic therapy with tissue plasminogen activator is effective for acute ischaemic stroke within 4·5 h of onset. Patients who wake up with stroke are generally ineligible for stroke thrombolysis. We hypothesized that ischaemic stroke patients with significant penumbral mismatch on either magnetic resonance imaging or computer tomography at three- (or 4·5 depending on local guidelines) to nine-hours from stroke onset, or patients with wake-up stroke within nine-hours from midpoint of sleep duration, would have improved clinical outcomes when given tissue plasminogen activator compared to placebo.EXtending the time for Thrombolysis in Emergency Neurological Deficits is an investigator-driven, Phase III, randomized, multicentre, double-blind, placebo-controlled study. Ischaemic stroke patients presenting after the three- or 4·5-h treatment window for tissue plasminogen activator and within nine-hours of stroke onset or with wake-up stroke within nine-hours from the midpoint of sleep duration, who fulfil clinical (National Institutes of Health Stroke Score ≥4-26 and prestroke modified Rankin Scale <2) will undergo magnetic resonance imaging or computer tomography. Patients who also meet imaging criteria (infarct core volume <70 ml, perfusion lesion : infarct core mismatch ratio >1·2, and absolute mismatch >10 ml) will be randomized to either tissue plasminogen activator or placebo.The primary outcome measure will be modified Rankin Scale 0-1 at day 90. Clinical secondary outcomes include categorical shift in modified Rankin Scale at 90 days, reduction in the National Institutes of Health Stroke Score by 8 or more points or reaching 0-1 at day 90, recurrent stroke, or death. Imaging secondary outcomes will include symptomatic intracranial haemorrhage, reperfusion and or recanalization at 24 h and infarct growth at day 90.en
dc.subject.otherDouble-Blind Methoden
dc.subject.otherFibrinolytic Agents.administration & dosageen
dc.subject.otherMagnetic Resonance Imagingen
dc.subject.otherMiddle Ageden
dc.subject.otherResearch Designen
dc.subject.otherStroke.drug therapy.pathologyen
dc.subject.otherThrombolytic Therapy.methodsen
dc.subject.otherTime Factorsen
dc.subject.otherTissue Plasminogen Activator.administration & dosageen
dc.subject.otherTomography, X-Ray Computeden
dc.titleA multicentre, randomized, double-blinded, placebo-controlled Phase III study to investigate EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND).en
dc.typeJournal Articleen
dc.identifier.journaltitleInternational Journal of Strokeen
dc.identifier.affiliationNational Stroke Research Institute, Florey Neuroscience Institutes, Austin Health, University of Melbourne, Heidelberg Heights, Victoria, Australiaen
dc.contributor.corpauthorEXTEND investigatorsen
Appears in Collections:Journal articles

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