European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ECASS-4: ExTEND

Amiri H, Bluhmki E, Bendszus M, Eschenfelder CC, Donnan GA, Leys D, Molina C, Ringleb PA, Schellinger PD, Schwab S, Toni D, Wahlgren N, Hacke W (2016)


Publication Type: Journal article

Publication year: 2016

Journal

Publisher: Wiley-Blackwell

Book Volume: 11

Pages Range: 260-7

Journal Issue: 2

DOI: 10.1177/1747493015620805

Abstract

Thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) is an effective and approved therapy for acute ischemic stroke within 4.5 h of onset except for USA, Canada, Croatia, and Moldovia with a current 3 h label. We hypothesized that ischemic stroke patients selected with significant penumbral mismatch on magnetic resonance imaging (MRI) at 4.5-9 h after onset of stroke will have improved clinical outcomes when given intravenous rt-PA (alteplase) compared to placebo.ECASS-4: ExTEND is an investigator driven, phase 3, randomized, multi-center, double-blind, placebo-controlled study. Ischemic stroke patients presenting within 4.5 and 9 h of stroke onset, who fulfil clinical requirements (National Institutes of Health Stroke Score (NIHSS) 4-26 and pre-stroke modified Rankin Scale (mRS) 0-1) will undergo MRI. Patients who meet imaging criteria (infarct core volume <100 ml, perfusion lesion: infarct core mismatch ratio >1.2 and perfusion lesion minimum volume of 20 ml) additionally will be randomized to either rt-PA or placebo.The primary outcome measure will be the categorical shift in the mRS at day 90. Clinical secondary outcomes will be disability at day 90 dichotomized as favorable outcome mRS 0-1 at day 90. Tertiary endpoints include reduction in the NIHSS by 11 or more points or reaching 0-1 at day 90, reperfusion and recanalization at 24 h post stroke as well as depression, life quality, and cognitive impairment at day 90. Safety endpoints will include symptomatic intracranial hemorrhage (ICH) and death.

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How to cite

APA:

Amiri, H., Bluhmki, E., Bendszus, M., Eschenfelder, C.C., Donnan, G.A., Leys, D.,... Hacke, W. (2016). European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ECASS-4: ExTEND. International Journal of Stroke, 11(2), 260-7. https://dx.doi.org/10.1177/1747493015620805

MLA:

Amiri, Hemasse, et al. "European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ECASS-4: ExTEND." International Journal of Stroke 11.2 (2016): 260-7.

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