title: [EU-funded treatment study: WAKE-UP: a randomized, placebo-controlled MRI-based trial of thrombolysis in wake-up stroke].
abstract: Patients waking up with stroke symptoms are generally excluded from intravenous thrombolysis. It was shown that magnetic resonance imaging (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. The WAKE-UP trial is an investigator initiated, European, randomized, double-blind, placebo-controlled trial designed to test efficacy and safety of MRI-based thrombolysis with alteplase (tPA) in stroke patients with unknown time of symptom onset, e.g. due to symptom recognition on awakening. A total of 800 patients showing MRI findings of a DWI-FLAIR-mismatch will be randomized to either tPA or placebo. The primary efficacy endpoint will be favourable outcome defined by a modified Rankin scale score 0-1 at day 90. The primary safety outcome measures will be mortality and death or dependency defined by modified Rankin scale score 4-6 at 90 days. If positive the WAKE-UP trial is expected to change clinical practice and to make effective and safe treatment available for a large group of acute stroke patients currently excluded from specific acute treatment.
authors.affiliation: Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Deutschland. thomalla@uke.uni-hamburg.de
authors.forename: G
authors.initials: G
authors.lastname: Thomalla
authors.forename: M
authors.initials: M
authors.lastname: Ebinger
authors.forename: J
authors.initials: J
authors.lastname: Fiehler
authors.forename: J B
authors.initials: JB
authors.lastname: Fiebach
authors.forename: M
authors.initials: M
authors.lastname: Endres
authors.forename: C
authors.initials: C
authors.lastname: Gerloff
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D038524:Diffusion Magnetic Resonance Imaging / Q000191:economics / Q000379:methods*; D004311:Double-Blind Method; D005060:Europe; D005062:European Union / Q000191:economics; D005260:Female; D005343:Fibrinolytic Agents / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D020521:Stroke / Q000175:diagnosis* / Q000188:drug therapy*; D015912:Thrombolytic Therapy / Q000191:economics; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005343:Fibrinolytic Agents