WAKE-UP
Research type
Research Study
Full title
Efficacy and safety of MRI-based thrombolysis in wake-up stroke: a randomised, double-blind, placebo-controlled trial
IRAS ID
107481
Contact name
Keith Muir
Sponsor organisation
Universitätsklinikum Hamburg-Eppendorf
Eudract number
2011-005906-32
Clinicaltrials.gov Identifier
Research summary
About 20% of strokes occur during sleep, and in many other cases the time of onset cannot be determined because of communication difficulties resulting from the stroke and lack of a witness. For patients waking up with stroke symptoms, or those with unknown time of onset, the only approved treatment ?? the delivery of the thrombolytic (??clot-busting?Â) drug rtPA ?? is unavailable to them. Currently, rtPA has only been proven effective when given to patients within 4.5 hours after the onset of stroke symptoms, and because there is concern about the risk of bleeding associated with treatment if given later, patients are not eligible for rtPA treatment if the onset time is unknown. The WAKE-UP trial will test the safety and effectiveness of rtPA treatment in patients who wake with stroke symptoms or have unknown onset time by using brain scanning with Magnetic Resonance Imaging (MRI) to identify whether the stroke was likely to have happened within the 4.5 hour time window. This can be done with a combination of two types of MRI scan, one that shows changes very quickly (diffusion-weighted imaging, DWI), and one where the changes take several hours to become obvious (FLAIR). Previous studies have shown that scans where the DWI is abnormal but the FLAIR normal identify patients with symptoms that started within 4.5 hours accurately. Patients with this appearance will be randomly allocated to receive intravenous rtPA or placebo, and followed up for 90 days to assess outcome.
REC name
Scotland A REC
REC reference
12/SS/0211
Date of REC Opinion
28 Nov 2012
REC opinion
Favourable Opinion