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Title: A multicentre, randomized, double-blinded, placebo-controlled Phase III study to investigate EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND).
Austin Authors: Ma, Henry K;Parsons, Mark W;Christensen, Soren;Campbell, Bruce C V;Churilov, Leonid ;Connelly, Alan;Yan, Bernard;Bladin, Christopher;Phan, Than;Barber, P Alan;Read, Stephen;Hankey, Graeme J;Markus, Romesh;Wijeratne, Tissa;Grimley, R;Mahant, N;Kleinig, Tim;Sturm, John;Lee, A;Blacker, D;Gerraty, Richard;Krause, M;Desmond, Patricia M;McBride, S J;Carey, Leeanne M ;Howells, David William;Hsu, C Y;Davis, Stephen M;Donnan, Geoffrey A 
Institutional Author: EXTEND investigators
Affiliation: National Stroke Research Institute, Florey Neuroscience Institutes, Austin Health, University of Melbourne, Heidelberg Heights, Victoria, Australia
Issue Date: 1-Jan-2012
Publication information: International Journal of Stroke; 7(1): 74-80
Abstract: Thrombolytic 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.
Gov't Doc #: 22188854
DOI: 10.1111/j.1747-4949.2011.00730.x
Journal: International Journal of Stroke
Type: Journal Article
Subjects: Double-Blind Method
Fibrinolytic Agents.administration & dosage
Magnetic Resonance Imaging
Middle Aged
Research Design
Stroke.drug therapy.pathology
Thrombolytic Therapy.methods
Time Factors
Tissue Plasminogen Activator.administration & dosage
Tomography, X-Ray Computed
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