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PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation

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.
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Coordinator

IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE

Address

South Kensington Campus Exhibition Road
Sw7 2az London

United Kingdom

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 3 391 070

Participants (11)

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UNIVERSITAETSKLINIKUM WUERZBURG - KLINIKUM DER BAYERISCHEN JULIUS-MAXIMILIANS-UNIVERSITAT

Germany

EU Contribution

€ 1 006 048,62

JULIUS-MAXIMILIANS-UNIVERSITAT WURZBURG

Germany

EU Contribution

€ 283 372,50

MEDIZINISCHE UNIVERSITAT GRAZ

Austria

EU Contribution

€ 329 975

THE UNIVERSITY OF BIRMINGHAM

United Kingdom

EU Contribution

€ 121 110

KING'S COLLEGE LONDON

United Kingdom

EU Contribution

€ 340 000

FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA

Spain

EU Contribution

€ 468 398

UNIVERSITE DE BORDEAUX

France

EU Contribution

€ 330 609,38

AZIENDA OSPEDALIERA DI PERUGIA

Italy

EU Contribution

€ 101 687,50

REGION NORDJYLLAND (NORTH DENMARK REGION)

Denmark

EU Contribution

€ 112 500

STROKE ALLIANCE FOR EUROPE

Belgium

EU Contribution

€ 45 000

UNIVERSITATSKLINIKUM HEIDELBERG

Germany

EU Contribution

€ 429 125

Project information

Grant agreement ID: 754517

Status

Ongoing project

  • Start date

    1 December 2017

  • End date

    30 November 2022

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 6 958 896

  • EU contribution

    € 6 958 896

Coordinated by:

IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE

United Kingdom