• Götz Thomalla, Jochen B Fiebach, Leif Østergaard, Salvador Pedraza, Vincent Thijs, Norbert Nighoghossian, Pascal Roy, Keith W Muir, Martin Ebinger, Bastian Cheng, Ivana Galinovic, Tae-Hee Cho, Josep Puig, Florent Boutitie, Claus Z Simonsen, Matthias Endres, Jens Fiehler, Christian Gerloff, and WAKE-UP investigators.
• Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
• Int J Stroke. 2014 Aug 1;9(6):829-36.

RationaleIn about 20% of acute ischemic stroke patients stroke occurs during sleep. These patients are generally excluded from intravenous thrombolysis. MRI can identify patients within the time-window for thrombolysis (≤4·5 h from symptom onset) by a mismatch between the acute ischemic lesion visible on diffusion weighted imaging (DWI) but not visible on fluid-attenuated inversion recovery (FLAIR) imaging.Aims And HypothesisThe study aims to test the efficacy and safety of MRI-guided thrombolysis with tissue plasminogen activator (rtPA) in ischemic stroke patients with unknown time of symptom onset, e.g., waking up with stroke symptoms. We hypothesize that stroke patients with unknown time of symptom onset with a DWI-FLAIR-mismatch pattern on MRI will have improved outcome when treated with rtPA compared to placebo.DesignWAKE-UP is an investigator initiated, European, multicentre, randomized, double-blind, placebo-controlled clinical trial. Patients with unknown time of symptom onset who fulfil clinical inclusion criteria (disabling neurological deficit, no contraindications against thrombolysis) will be studied by MRI. Patients with MRI findings of a DWI-FLAIR-mismatch will be randomised to either treatment with rtPA or placebo.Study OutcomeThe primary efficacy endpoint will be favourable outcome defined by modified Rankin Scale 0-1 at day 90. The primary safety outcome measures will be mortality and death or dependency defined by modified Rankin Scale 4-6 at 90 days.DiscussionIf positive, WAKE-UP is expected to change clinical practice making effective and safe treatment available for a large group of acute stroke patients currently excluded from specific acute therapy.© 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

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