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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. €

0

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.

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

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.
telephone: 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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