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- Title
EU-geförderte Therapiestudie WAKE-UP.
- Authors
Thomalla, G.; Ebinger, M.; Fiehler, J.; Fiebach, J.B.; Endres, M.; Gerloff, C.
- 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.
- Subjects
STROKE; THROMBOLYTIC therapy; MAGNETIC resonance imaging; PLACEBOS; SLEEP-wake cycle
- Publication
Der Nervenarzt, 2012, Vol 83, Issue 10, p1241
- ISSN
0028-2804
- Publication type
Article
- DOI
10.1007/s00115-012-3532-7