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

Daiichi Sankyo

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Edoxaban

Study type: Observational

Funder types: Industry

Identifiers

NCT02944019

DSE-EDO-04-14-EU

Details and patient eligibility

About

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.

Full 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).

Enrollment: 13,980 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• NVAF-patients treated with edoxaban according to Summary of Product Characteristics (SmPC).
• Written informed consent for participation in the study (ICF).
• Not simultaneously participating in any interventional study.

Exclusion criteria

• None

Trial design

13,980 participants in 1 patient group

Edoxaban

Description:

Patients with established Non Valvular Atrial Fibrillation (NVAF) treated with edoxaban according to Summary of Product Characteristics (SmPC). Physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban.

Treatment:

Drug: Edoxaban