The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)

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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02973984

Acronym

EUROSAF

Enrollment

3000

Registered

2016-11-28

Start date

2016-11-18

Completion date

2024-12-31

Last updated

2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Anticoagulant Treatments, Multidimensional Prognostic Index (MPI), Comprehensive Geriatric Assessment (CGA), Frailty, Elderly, Atrial Fibrillation

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
all-cause mortality and vascular mortality	12 months	Vascular mortality is defined as: stroke, embolism, myocardial infarction
thromboembolic events,	12 months	stroke and/or systemic embolism
bleeding side-effects	12 months	major intracranial and gastrointestinal bleeding.

Secondary

Measure	Time frame	Description
vascular-related hospitalization rates	12 months	stroke and/or systemic embolism
presence/absence of anticoagulant treatments	12 months	presence of anticoagulant treatments
bleeding-related hospitalization rates	12 months	intracranial and gastrointestinal bleeding
MPI value and different mortality risk class	12 months	mild, moderate, severe

Countries

Italy

Contacts

Primary ContactAlberto Pilotto, MD

alberto.pilotto@galliera.it0039 010 563

Backup ContactAlessandra Argusti, PDH

a.argusti@galliera.it0039 010 563

Outcome results