• Henry Ma, Mark W Parsons, Soren Christensen, Bruce C V Campbell, Leonid Churilov, Alan Connelly, Bernard Yan, Chris Bladin, Than Phan, Alan P Barber, Stephen Read, Graeme J Hankey, Romesh Markus, Tissa Wijeratne, R Grimley, N Mahant, Tim Kleinig, John Sturm, A Lee, D Blacker, Richard Gerraty, M Krause, P M Desmond, S J McBride, Leanne Carey, David W Howells, C Y Hsu, Stephen M Davis, Geoffrey A Donnan, and EXTEND investigators.
• National Stroke Research Institute, Florey Neuroscience Institutes, Austin Health, University of Melbourne, Heidelberg Heights, Victoria, Australia.
• Int J Stroke. 2012 Jan 1;7(1):74-80.

Background And HypothesisThrombolytic 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.Study DesignEXtending 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.Study OutcomeThe 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.© 2011 The Authors. International Journal of Stroke © 2011 World Stroke Organization.

18 keywords...

hide…