WAKE-UP

"Efficacy and safety of MRI-based thrombolysis in wake-up stroke: a randomised, double-blind, placebo-controlled trial"

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 Obiettivo del progetto (Objective)

'WAKE-UP is an investigator-initiated, multicentre, randomised, double-blind, placebo-controlled trial designed to test efficacy and safety of MRI-based intravenous thrombolysis in patients with wake-up stroke. Every year 1.5 million patients suffer a stroke in the EU. Up to 20% of stroke patients wake up with stroke symptoms. Currently these patients are excluded from thrombolysis which is the only approved specific treatment available for acute stroke. However, recently the potential of MRI to identify patients likely to be within a time-window for thrombolysis (≤4.5 hours) was demonstrated. WAKE-UP will use a specific MRI pattern, i.e. the mismatch between a visible lesion on diffusion weighted imaging (DWI) and a normal fluid attenuated inversion recovery (FLAIR) image, to randomise patients waking up with stroke symptoms to either treatment with Alteplase or placebo. The primary endpoint will be favourable outcome at 3 months. A total of 800 patients will be enrolled in 40 centres in six EU countries. Additional MRI information such as vessel occlusion or perfusion lesion will not be used for enrolment but will be studied as possible modifiers of the response to thrombolysis. Software will be developed to facilitate the processing and analysis of multiparametric stroke MRI and to assist the integration of modern stroke imaging into acute treatment decisions. The trial will be accompanied by activities increasing the awareness for acute stroke in the public and results will be disseminated within the scientific community as well as within the public. WAKE-UP is aimed to promote a paradigm-change in acute stroke treatment, and to provide effective treatment to a large new group of patients. The results of WAKE-UP are expected to change guidelines of acute stroke management and clinical practice. WAKE-UP will help to reduce the burden of stroke related disability in the EU.'

Introduzione (Teaser)

Currently, acute stroke treatment depends on knowing when the symptoms began. A European consortium is working on a method to determine the time window for therapy.

Descrizione progetto (Article)

Every year 1.5 million patients suffer a stroke in the EU. Intravenous thrombolysis with recombinant tissue plasminogen activator is the only effective and approved specific treatment when administered within 4.5 hours of an acute ischaemic stroke episode. In nearly one fifth of the patients it is not possible to estimate the precise time of the episode making them unsuitable for thrombolysis.

The EU-funded http://www.wakeup-stroke.eu/ (WAKE-UP) (Efficacy and safety of MRI-based thrombolysis in wake-up stroke: a randomised, double-blind, placebo-controlled trial) project has been designed for these patients. The consortium is using magnetic resonance imaging (MRI) to determine if stroke patients remain within the 4.5 hour therapeutic window. Based on this technique, patients waking up with stroke symptoms will be randomised for treatment with thrombolysis.

During the first part of the project, image processing and software has been optimised for quantifying lesion volumes in stroke patients. Considerable work has gone into the image training of over 300 clinicians in 58 sites. Over 775 patients have been enrolled in the trial and 280 patients have been randomised. Data analysis is currently in progress, and partners are also examining the effect of thrombolysis depending on vessel occlusion or perfusion lesion.

Overall, the WAKE-UP study addresses the massive and growing health problem of stroke management. The outcome of the clinical trial will provide unquestionable evidence for the efficacy and safety of MRI-based thrombolysis.

It is anticipated that the project findings will change the guidelines of acute stroke management and become immediately implemented, harmonising stroke treatment across the EU. Long term this approach will allow specific treatment recommendations for acute stroke patients with unknown symptom onset. A 10 % absolute increase in the rate of patients with no or minimal deficit after stroke is envisaged for stroke patients through prompt thrombolysis treatment.