NCT02944019

Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13,980 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Edoxaban	Prescribed according to approved label

Timeline

• Start date: 2015-08-01
• Primary completion: 2022-04-13
• Completion: 2022-04-13
• First posted: 2016-10-25
• Last updated: 2022-06-01

Locations

724 sites across 10 countries: Austria, Belgium, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom