1. European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ECASS-4: ExTEND.
- Author
-
Amiri, Hemasse, Bluhmki, Erich, Bendszus, Martin, Eschenfelder, Christoph C., Donnan, Geoffrey A., Leys, Didier, Molina, Carlos, Ringleb, Peter A., Schellinger, Peter D., Schwab, Stefan, Toni, Danilo, Wahlgren, Nils, and Hacke, Werner
- Subjects
THROMBOLYTIC therapy ,PLASMINOGEN activators ,MAGNETIC resonance imaging ,STROKE patients ,STROKE treatment ,RANDOMIZED controlled trials - Abstract
Rationale and hypothesis: 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. Study design: ECASS-4: ExTEND is an investigator driven, phase 3, randomized, multi-center, double-blind, placebocontrolled 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. Study outcome: 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. [ABSTRACT FROM AUTHOR]
- Published
- 2016
- Full Text
- View/download PDF