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PRESTIGE-AF SIGNED

PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation

Total Cost €

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EC-Contrib. €

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Partnership

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 PRESTIGE-AF project word cloud

Explore the words cloud of the PRESTIGE-AF project. It provides you a very rough idea of what is the project "PRESTIGE-AF" about.

oac    powered    randomized    mri    sufficiently    expectancy    anticoagulants    population    quality    balance    blood    patients    perform    oral    settings    bleeding    trials    co    follow    hierarchical    prevented    genetics    survivors    fibrillation    causing    versus    size    regarding    prospective    outcome    data    mortality    individual    disability    severe    biomarkers    inferior    therapy    ich    subtype    model    economic    generalizability    individualized    integrating    direct    clinical    atrial    gender    prevention    antithrombotic    generally    reduces    modeling    tools    desirable    life    tailor    prestige    health    outputs    uncertain    societal    personalize    baseline    primary    recurrent    endpoint    packages    antiplatelet    replication    generate    recurrence    dilemma    centers    personalized    hemorrhage    662    countries    rct    prediction    explore    trial    tool    af    ischemic    recruit    imbalances    public    attitudes    patient    benefits    relevance    unmet    superior    estimate    20    adherence    risk    intracerebral    biological    centered    blinded    sequential    multidimensional    strokes    stroke    first    enrollment   

Project "PRESTIGE-AF" data sheet

The following table provides information about the project.

Coordinator
IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE 

Organization address
address: SOUTH KENSINGTON CAMPUS EXHIBITION ROAD
city: LONDON
postcode: SW7 2AZ
website: http://www.imperial.ac.uk/

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
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 Coordinator Country United Kingdom [UK]
 Total cost 6˙958˙896 €
 EC max contribution 6˙958˙896 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2017-Two-Stage-RTD
 Funding Scheme RIA
 Starting year 2017
 Duration (year-month-day) from 2017-12-01   to  2022-11-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE UK (LONDON) coordinator 3˙332˙520.00
2    UNIVERSITAETSKLINIKUM WUERZBURG - KLINIKUM DER BAYERISCHEN JULIUS-MAXIMILIANS-UNIVERSITAT DE (WURZBURG) participant 1˙019˙373.00
3    FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA ES (BARCELONA) participant 468˙398.00
4    UNIVERSITATSKLINIKUM HEIDELBERG DE (HEIDELBERG) participant 447˙700.00
5    MEDIZINISCHE UNIVERSITAT GRAZ AT (GRAZ) participant 343˙300.00
6    KING'S COLLEGE LONDON UK (LONDON) participant 340˙000.00
7    UNIVERSITE DE BORDEAUX FR (BORDEAUX) participant 330˙609.00
8    JULIUS-MAXIMILIANS-UNIVERSITAT WURZBURG DE (WUERZBURG) participant 283˙372.00
9    THE UNIVERSITY OF LIVERPOOL UK (LIVERPOOL) participant 116˙562.00
10    AZIENDA OSPEDALIERA DI PERUGIA IT (PERUGIA) participant 115˙012.00
11    REGION NORDJYLLAND (NORTH DENMARK REGION) DK (AALBORG) participant 112˙500.00
12    STROKE ALLIANCE FOR EUROPE BE (BRUSSELS) participant 45˙000.00
13    THE UNIVERSITY OF BIRMINGHAM UK (BIRMINGHAM) participant 4˙547.00

Map

 Project 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.

 Deliverables

List of deliverables.
First study subject approvals package Documents, reports 2020-03-24 00:29:29
Educational video on“Sample Collection Methods for Biomarker Studies” Websites, patent fillings, videos etc. 2020-03-24 00:29:29
PRESTIGE-AF “Dissemination Package” Other 2020-03-24 00:29:29
Launch of website and social media accounts Websites, patent fillings, videos etc. 2020-03-24 00:29:29
Dissemination & Communication Plan Documents, reports 2020-03-24 00:29:29

Take a look to the deliverables list in detail:  detailed list of PRESTIGE-AF deliverables.

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