Clinical trial NCT02973984: The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)
Official title: Evaluating the Efficacy and Risks of Anticoagulant Treatments in Multimorbid Frail Older Subjects With Atrial Fibrillation. The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: Anticoagulant Treatments
Multidimensional Prognostic Index (MPI)
Comprehensive Geriatric Assessment (CGA)
Frailty
Elderly
Atrial Fibrillation
Lead sponsor: Ente Ospedaliero Ospedali Galliera
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2016-11-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a cross-national, prospective, observational study that will include about 3.000 older subjects (aged ≥ 65 years) with AF hospitalized in 30 European geriatric centers (about 100 subjects/center) for an acute disease or a relapse of a chronic diseases. The study is in the frame of the Special Interest Group on CGA (Comprehensive Geriatric Assessment) of the EUGMS (European Union Geriatric Medicine Society).

Brief summary: Preliminary data suggest that:

1. a different risk of mortality, as assessed by the Multidimensional Prognostic Indices (MPI), may influence the anticoagulant prescription in older subjects with Atrial Fibrillation (AF);
2. the presence of multidimensional impairment, disability and multi-morbidities are usually not included in the decision algorithm of the more appropriate treatments in older patients with AF;
3. considering the prognostic information, as calculated by the MPI, can be useful to physicians in identifying older patients with AF that can benefit from anticoagulant treatment in term of increased survival.

Detailed description: The main objective of this observational study is to evaluate in a "real world" population of older hospitalized patients with AF, the clinical benefit/risk ratio of the anticoagulant treatments in terms of:

1. mortality (all-cause and vascular mortality);
2. thromboembolic events, i.e. stroke, systemic embolism;
3. bleeding side-effects, especially intracranial and gastrointestinal bleeding Secondary objective of the study is to evaluate whether a different prognostic profile, as determined by the MPI, is associated with 1) different kind of treatments for AF (no treatment vs anticoagulants, i.e. Vitamin K Antagonists (VKA) or novel oral anticoagulant (NOACs); and 2) differences in the main outcomes (i.e. mortality, major thromboembolic events and side effects including bleeding events).

Eligibility criteria: Inclusion Criteria:

This is an observational study in which all consecutive patients admitted to the Geriatrics Units involved in the project will be screened for inclusion. The inclusion criteria are:

1. patients of both genders, aged 65 years and older
2. admitted to hospital for acute diseases or a relapse of chronic diseases
3. with a documented diagnosis of non valvular AF
4. who are willing to participate in the survey and give their informed consent

Exclusion Criteria:

1. age less than 65 years
2. patients who have not provided informed consent

Primary outcomes:
measure: all-cause mortality and vascular mortality
timeFrame: 12 months
measure: thromboembolic events,
timeFrame: 12 months
measure: bleeding side-effects
timeFrame: 12 months
Secondary outcomes:
measure: vascular-related hospitalization rates
timeFrame: 12 months
measure: bleeding-related hospitalization rates
timeFrame: 12 months
measure: MPI value and different mortality risk class
timeFrame: 12 months
measure: presence/absence of anticoagulant treatments
timeFrame: 12 months
Other outcomes:
Locations:
city: Genova
country: Italy
facility: S.C. Geriatria
Study officials:
affiliation: Dipartimento: area delle cure geriatriche, ortogeriatria e riabilitazione - E.O. Ospedali Galliera - Genova Italy
name: Alberto Pilotto, MD
role: PRINCIPAL_INVESTIGATOR
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