Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation — ETNA-AF-EU  

Atrial Fibrillation Clinical Trial

Official title: Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation

Status Completed

Clinical Trial Summary

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the Non-valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed this post-authorization safety study (PASS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) of edoxaban use in patients with NVAF who were not preselected.

Clinical Trial Description

Patients will be from 10 different European countries and care settings (primary and secondary care and different specialties). A one-year patient recruitment period per country is planned, but it could be longer if patient recruitment numbers are not reached. Patient data will be documented at baseline (BL), one annual data documentation point during the four-year follow up (FU), and at final assessment. Patients who permanently discontinue edoxaban during the observation period will continue to be followed annually for a further two years, or until the end of the observational period (whichever comes first). ;

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT02944019
• Study type: Observational
• Source: Daiichi Sankyo, Inc.
• Status: Completed
• Start date: August 2015
• Completion date: April 13, 2022