WAKE-UP trial starts in the UK

Aug 11 2013

WAKE-UP - a large European clinical trial to test whether current rtPA for stroke thrombolysis  treatments can be used in patients who wake up with the symptoms of stroke. The first patients were enrolled in UK at the Southern General Hospital this week.



Every year about two million patients have a stroke in the EU. Up to 20 per cent of stroke patients wake up with stroke symptoms so the time the stroke started is unknown. This makes patients ineligible for the only approved treatment for acute stroke-

The WAKE-UP trial is recruiting 800 patients across Europe and will test the effectiveness and safety of rtPA treatment in patients who wake up with stroke symptoms. It will use MRI scans to identify whether the stroke was likely to have happened within the four and a half hour time window, making the patient eligible to receive rtPA treatment.


In the UK, the trial, which is funded by the European Union's Framework 7 programme, is being coordinated by Professor Keith Muir at the University of Glasgow.


Professor Muir explained, "We will use a combination of two different MRI scans to predict whether a patient is within four and a half hours of stroke onset. The first scan, called diffusion weighted imaging (DWI), shows early changes in the brain after stroke whereas changes take several hours to become obvious in the second type of scan called FLAIR."


"We know from previous studies that patients who have changes in their DWI scan but not in their FLAIR scan are very likely to be within four and a half hours from the start of their stroke. Patients waking up with a stroke that show this correct pattern of MRI scans will be enrolled in the trial. They will be randomly assigned to either receive intravenous rtPA treatment or a placebo and then followed up for 90 days to assess their outcome."


More than 40 sites across Europe have been identified to take part in the five-year study. In the UK, 7 sites will participate: Southerh General Hospital (Glasgow) Addenbrooke's Hospital (Cambridge), University College London Hospitals (London), St George's Hospital (London), King's College Hospital (London), University Hospital of North Staffordshire NHS Trust (North Staffordshire) and Salford Royal NHS Foundation Trust (Salford).


Dr Clare Walton from the Stroke Association said: "WAKE-UP is a positive step towards addressing one of the largest health issues in the EU and has the potential to change the way we treat stroke."


"If administering rtPA is found to be safe and effective in patients who wake with stroke symptoms, we could see improved recovery for thousands of stroke survivors."


WAKE-UP brings together leading stroke researchers from European academic institutions, highly specialised partners, and patient organisations providing a wide range of clinical and scientific expertise in stroke, image processing, and the conduction of clinical trials.


To find out more about the WAKE-UP trial. Visit http://www.wakeup-stroke.eu/