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PRESTIGE-AF

financed

PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrilla...

PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation 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 p... see more

30/11/2024

IMPERIAL COLLEGE O...

7M€

Project Budget: 7M€

Project leader

IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND ME... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

PARTICIPATION DEPralty Sin fecha límite de participación.

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Financing granted El organismo H2020 notifico la concesión del proyecto The day 2024-11-30

SC1-PM-10-2017: Comparing the effectiveness of exis... Specific Challenge:Effective health care and prevention may be improved by additional evidence as to...

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Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

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14 Participantes

IMPERIAL COLLEGE OF SCIENCE...

3.32M€ | Leader

KINGS COLLEGE LONDON

340.00K€ | participant

UoB

4.55K€ | participant

BELSPO

45.00K€ | participant

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Project duration: 83 months Date Start: 2017-12-05
End date: 2024-11-30

Project leader

IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND ME... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Project Budget 7M€

participation deadline Sin fecha límite de participación.

Project description 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 expected: 314-420 patients. RCT will recruit in 70 centers in 6 countries over 4-5 years with a mean 2-year follow-up (minimum 6 months, maximum 36 months). 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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