NCT02973984

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
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Alberto Pilotto · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2016-11-18
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2016-11-28
• Last updated: 2023-09-07

Locations

1 site across 1 country: Italy