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 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.
Fields of science (EuroSciVoc)
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This project's classification has been validated by the project's team.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
This project's classification has been validated by the project's team.
Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being
MAIN PROGRAMME
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H2020-EU.3.1.3. - Treating and managing disease
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
RIA - Research and Innovation action
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) H2020-SC1-2016-2017
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
SW7 2AZ LONDON
United Kingdom
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.