The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF) (EUROSAF)
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ClinicalTrials.gov Identifier: NCT02973984 |
Recruitment Status :
Recruiting
First Posted : November 28, 2016
Last Update Posted : August 17, 2021
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Preliminary data suggest that:
- 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);
- 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;
- 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.
Condition or disease |
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Atrial Fibrillation |
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:
- mortality (all-cause and vascular mortality);
- thromboembolic events, i.e. stroke, systemic embolism;
- 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 Type : | Observational |
Estimated Enrollment : | 3000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 Start Date : | November 18, 2016 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |

- all-cause mortality and vascular mortality [ Time Frame: 12 months ]Vascular mortality is defined as: stroke, embolism, myocardial infarction
- thromboembolic events, [ Time Frame: 12 months ]stroke and/or systemic embolism
- bleeding side-effects [ Time Frame: 12 months ]major intracranial and gastrointestinal bleeding.
- vascular-related hospitalization rates [ Time Frame: 12 months ]stroke and/or systemic embolism
- bleeding-related hospitalization rates [ Time Frame: 12 months ]intracranial and gastrointestinal bleeding
- MPI value and different mortality risk class [ Time Frame: 12 months ]mild, moderate, severe
- presence/absence of anticoagulant treatments [ Time Frame: 12 months ]presence of anticoagulant treatments

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:
- patients of both genders, aged 65 years and older
- admitted to hospital for acute diseases or a relapse of chronic diseases
- with a documented diagnosis of non valvular AF
- who are willing to participate in the survey and give their informed consent
Exclusion Criteria:
- age less than 65 years
- patients who have not provided informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973984
Contact: Alberto Pilotto, MD | 0039 010 563 ext 4467 | alberto.pilotto@galliera.it | |
Contact: Alessandra Argusti, PDH | 0039 010 563 ext 4188 | a.argusti@galliera.it |
Italy | |
S.C. Geriatria | Recruiting |
Genova, Italy, 16128 | |
Contact: Alberto Pilotto, MD 0039 010 536 ext 4467 alberto.pilotto@galliera.it |
Principal Investigator: | Alberto Pilotto, MD | Dipartimento: area delle cure geriatriche, ortogeriatria e riabilitazione - E.O. Ospedali Galliera - Genova Italy |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Alberto Pilotto, Director of Department Geriatric Care, OrthoGeriatrics and Rehabilitation, Ente Ospedaliero Ospedali Galliera |
ClinicalTrials.gov Identifier: | NCT02973984 |
Other Study ID Numbers: |
28UCS2015 162REG2016 ( Other Identifier: Ethics Commitee of the Liguria Region ) |
First Posted: | November 28, 2016 Key Record Dates |
Last Update Posted: | August 17, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Anticoagulant Treatments Multidimensional Prognostic Index (MPI) Comprehensive Geriatric Assessment (CGA) |
Frailty Elderly Atrial Fibrillation |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |