CLINICAL TRIAL: https://clinicaltrials.gov/ct2/show/NCT02973984
Trial identifier NCT02973984, 162REG2016, 28UCS2015
EUROSAF is an observational study aiming at evaluating the efficacy and risks of anticoagulant treatments in multi-morbid frail older subjects with Atrial Fibrillation, through a multi-center analysis including old patients (over 65) affected by atrial fibrillation and hospitalized several Geriatric Wards in Europe. This study is performed in the framework of the Special Interest Group on Comprehensive Geriatric Assessment (SIG - on - CGA), supported by the European Geriatric Medicine Society (EuGMS). The involved centers are located in 10 different countries.
The main objective of the study is to evaluate in a population of hospitalized older subjects with AF the clinical benefit/risk ratio of the anticoagulant treatments in terms of:
- mortality (all-cause and vascular mortality);
- thromboembolic events, i.e. stroke, systemic embolism
- bleeding side-effects, especially intracranial and gastrointestinal bleeding.
Secondary objectives of the study are to evaluate whether a different prognostic profile, as determined by the MPI, is associated with:
- different treatments for AF (no treatment vs anticoagulants, i.e. VKA or NOACs); and
- differences in the main outcomes, i.e. mortality, thromboembolic events and side effects including bleeding events.
PROMOTER: E.O. Galliera Hospital – National Relevance and High Specialization Hospital, Genoa, Italy