Skip to main content

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

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.

Field of science

  • /medical and health sciences/basic medicine/neurology/stroke

Call for proposal

FP7-HEALTH-2011-two-stage
See other projects for this call

Funding Scheme

CP-IP - Large-scale integrating project

Coordinator

UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF
Address
Martinistrasse 52
20251 Hamburg
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 2 653 358
Administrative Contact
Christian Gerloff (Prof.)

Participants (12)

AARHUS UNIVERSITETSHOSPITAL
Denmark
EU contribution
€ 689 108
Address
Palle Juul-jensens Boulevard 99
8200 Aarhus
Activity type
Research Organisations
Administrative Contact
John Westensee (Mr.)
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
EU contribution
€ 1 389 587
Address
Chariteplatz 1
10117 Berlin
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Eveline Fraessdorf (Ms.)
FUNDACIO INSTITUT D'INVESTIGACIO BIOMEDICA DE GIRONA DOCTOR JOSEP TRUETA
Spain
EU contribution
€ 795 658
Address
Calle Dr. Castany Sn Edificio De La Mancomunidad 2 Parque Hospitalario Marti Julia
17190 Girona
Activity type
Research Organisations
Administrative Contact
Núria Chico (Ms.)
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 1 088 174
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Sofie Heroes (Ms.)
HOSPICES CIVILS DE LYON
France
EU contribution
€ 861 767
Address
Quai Des Celestins 3
69002 Lyon
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Cécile Legros (Ms.)
UNIVERSITY OF GLASGOW
United Kingdom
EU contribution
€ 1 171 858
Address
University Avenue
G12 8QQ Glasgow
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Joe Galloway (Mr.)
STROKE ALLIANCE FOR EUROPE
Belgium
EU contribution
€ 84 822
Address
Rue Washington 40
1050 Brussels
Activity type
Other
Administrative Contact
Chatarina Lindgren (Ms.)
FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.
Germany
EU contribution
€ 257 031
Address
Hansastrasse 27C
80686 Munchen
Activity type
Research Organisations
Administrative Contact
Christoph Schulte (Mr.)
MEDIRI GMBH
Germany
EU contribution
€ 416 640
Address
Eppelheimer Str 13
69115 Heidelberg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Johannes Gregori (Dr.)
ZYTOSERVICE DEUTSCHLAND GMBH
Germany
EU contribution
€ 1 075 000
Address
Albert Schweitzer Ring 18
22045 Hamburg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Mirco Schaecke (Dr.)
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Participation ended

Germany
EU contribution
€ 209 458
Address
Oskar Von Miller Ring 29
80333 Muenchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Birgit Fuchs (Ms.)
ORION CLINICAL SERVICES LTD
United Kingdom
EU contribution
€ 907 526
Address
Bath Road 7
SL13UA Slough
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Paul Hunter (Mr.)