WAKE-UP – a large European clinical trial to test whether current ‘clot dissolving’ treatments can be used in people who wake up with the symptoms of stroke enrolled the first UK patients 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 delivery the thrombolytic or ‘clot dissolving’ drug rtPA. Currently, rtPA is only approved for patients within four and half hours after the start of stroke symptoms, and because there is concern about the risk of bleeding associated with treatment if given later, patients are not treated if the onset time is unknown.
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 brain Magnetic Resonance Imaging (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/
A stroke is a brain attack which happens when the blood supply to the brain is cut off, caused by a clot or bleeding in the brain. Around 150,000 people have a stroke in the UK every year and it is the leading cause of severe adult disability. There are over one million people in UK living with the effects of stroke.
The WAKE-UP trial will enrol patients that have acute ischaemic stroke – the kind of stroke caused by a blood clot. Ischaemic strokes account for about 80% of all strokes.
The WAKE-UP trial is funded by the European Commission within the Framework 7 Programme and is being led by Prof Christian Gerloff and Dr. Götz Thomalla from the University Medical Center Hamburg-Eppendorf in Hamburg, Germany.
A stroke can be diagnosed using FAST:
- Facial weakness – has the person’s face drooped, usually down one side
- Arm weakness – is the person able to lift both arms above their head
- Speech problems – does the person’s speech sound slurred
- Time to call 999 – if one or more of these symptoms are present call 999 immediately.