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

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT02973984
• Lead Sponsor: Alberto Pilotto

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).

Study Timeline

• Study First Submitted: 2016-10-24
• Study Start: 2016-11-18
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bleeding side-effects	12 months	major intracranial and gastrointestinal bleeding.
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

S.C. Geriatria; 🇮🇹 Genova, Italy