Document Detail


EU-funded treatment study: WAKE-UP : A randomized, placebo-controlled MRI-based trial of thrombolysis in wake-up stroke.
MedLine Citation:
PMID:  23015193     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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:
G Thomalla; M Ebinger; J Fiehler; J B Fiebach; M Endres; C Gerloff
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-28
Journal Detail:
Title:  Der Nervenarzt     Volume:  -     ISSN:  1433-0407     ISO Abbreviation:  Nervenarzt     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-27     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0400773     Medline TA:  Nervenarzt     Country:  -    
Other Details:
Languages:  GER     Pagination:  -     Citation Subset:  -    
Affiliation:
Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Deutschland, thomalla@uke.uni-hamburg.de.
Vernacular Title:
EU-geförderte Therapiestudie WAKE-UP : Eine randomisierte, placebokontrollierte, MRT-basierte Thrombolysestudie bei "wake-up stroke"
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