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PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation

Objective

Intracerebral hemorrhage (ICH) is a severe stroke subtype causing higher mortality and more disability than other strokes. 20% of ICH survivors have atrial fibrillation (AF), a major cause of ischemic stroke (IS). While IS in AF patients is generally prevented by oral anticoagulants (OAC), their use in ICH survivors is uncertain due to increased bleeding risk. No evidence from randomized controlled trials (RCT) is available addressing this dilemma. Personalized risk prediction is desirable to balance benefits of OAC against bleeding risk for individualized prevention.

Objectives: (1) To perform the first sufficiently powered RCT in ICH survivors with AF testing if direct OAC are superior for IS prevention and non-inferior regarding ICH recurrence versus antiplatelet or no antithrombotic therapy (2) To personalize antithrombotic prevention by multidimensional risk modeling (3) To estimate population impact of trial outputs on health economic consequences and generalizability to European population (4) To explore patient-centered aspects including adherence, attitudes towards antithrombotic therapy and gender imbalances in trial enrollment.

Methods: Prospective, open RCT with blinded outcome assessment. Hierarchical sequential testing of co-primary endpoint IS and recurrent ICH. Sample size: 662 patients. RCT will recruit in 70 centers in 6 countries over 2 years with 2 year follow-up. Clinical characteristics, MRI, blood-biomarkers and genetics will be characterized at baseline to model a new personalized risk prediction tool.

Relevance for work program: PRESTIGE-AF addresses the unmet need of best antithrombotic stroke prevention in ICH patients with AF. Recurrent stroke reduces individual life expectancy, quality of life and has high public health impact. Work packages integrating biological data will generate new tools to tailor prevention. Modeling of economic and societal consequences and replication in real-life settings will estimate population impact.

Call for proposal

H2020-SC1-2016-2017

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Sub call

H2020-SC1-2017-Two-Stage-RTD

Coordinator

IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE
Net EU contribution
€ 3 319 195,00
Address
South Kensington Campus Exhibition Road
SW7 2AZ London
United Kingdom

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Region
London Inner London — West Westminster
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00

Participants (13)

UNIVERSITAETSKLINIKUM WUERZBURG - KLINIKUM DER BAYERISCHEN JULIUS-MAXIMILIANS-UNIVERSITAT
Germany
Net EU contribution
€ 1 019 373,62
Address
Josef-schneider-strasse 2
97080 Wurzburg

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Region
Bayern Unterfranken Würzburg, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
JULIUS-MAXIMILIANS-UNIVERSITAT WURZBURG
Germany
Net EU contribution
€ 283 372,50
Address
Sanderring 2
97070 Wuerzburg

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Region
Bayern Unterfranken Würzburg, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
MEDIZINISCHE UNIVERSITAT GRAZ
Austria
Net EU contribution
€ 343 300,00
Address
Auenbruggerplatz 2
8036 Graz

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Region
Südösterreich Steiermark Graz
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
THE UNIVERSITY OF BIRMINGHAM

Participation ended

United Kingdom
Net EU contribution
€ 4 547,66
Address
Edgbaston
B15 2TT Birmingham

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Region
West Midlands (England) West Midlands Birmingham
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
KING'S COLLEGE LONDON
United Kingdom
Net EU contribution
€ 340 000,00
Address
Strand
WC2R 2LS London

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Region
London Inner London — West Westminster
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA
Spain
Net EU contribution
€ 481 723,00
Address
Passeig Vall D Hebron 119-129 Edificio De Recerca
08035 Barcelona

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Non-EU contribution
€ 0,00
UNIVERSITE DE BORDEAUX
France
Net EU contribution
€ 275 000,00
Address
Place Pey Berland 35
33000 Bordeaux

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Region
Nouvelle-Aquitaine Aquitaine Gironde
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

CHU HOPITAUX DE BORDEAUX
France
Net EU contribution
€ 55 609,38
Address
Rue Dubernat 12
33404 Talence

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Region
Nouvelle-Aquitaine Aquitaine Gironde
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
AZIENDA OSPEDALIERA DI PERUGIA
Italy
Net EU contribution
€ 115 012,50
Address
S Andrea Delle Fratte
06156 Perugia

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Region
Centro (IT) Umbria Perugia
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
REGION NORDJYLLAND (NORTH DENMARK REGION)
Denmark
Net EU contribution
€ 112 500,00
Address
Niels Bohrs Vej 30
9220 Aalborg

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Region
Danmark Nordjylland Nordjylland
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
STROKE ALLIANCE FOR EUROPE
Belgium
Net EU contribution
€ 45 000,00
Address
Rue Washington 40
1050 Brussels

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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Other
Non-EU contribution
€ 0,00
UNIVERSITATSKLINIKUM HEIDELBERG
Germany
Net EU contribution
€ 447 700,00
Address
Im Neuenheimer Feld 672
69120 Heidelberg

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Region
Baden-Württemberg Karlsruhe Heidelberg, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
THE UNIVERSITY OF LIVERPOOL
United Kingdom
Net EU contribution
€ 116 562,34
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool

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Region
North West (England) Merseyside Liverpool
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00