PRESTIGE-AF SIGNED
PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation
Total Cost €
0EC-Contrib. €
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Project "PRESTIGE-AF" data sheet
The following table provides information about the project.
| Coordinator |
IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE
Organization address contact info |
| 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
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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
| 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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