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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.

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

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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