Non-interventional study on 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 - ETNA-AF-Europe

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00007912

Enrollment

13100

Registered

2015-07-30

Start date

2015-08-14

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA - 10003658: Atrial fibrillation I48

Interventions

Group 1: - Patients from different countries and care settings (primary and secondary care and different specialties) with non-valvular atrial fibrillation treated with Edoxaban according to Summary o

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with non-valvular atrial fibrillation treated with Edoxaban according to Summary of Product Characteristics (SmPC). Written informed consent for participation in the study Not simultaneously participating in any interventional study As this is a non-interventional study, no additional selection criteria apply. Patients will only be included in the study after the treating physician has made the clinical decision to prescribe Edoxaban. The prescribing behaviour will not be influenced.

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to collect real-world safety data on bleeding events including intracranial haemorrhage, drug related adverse events such as liver adverse events, cardiovascular (CV) and all-cause mortality in AF patients treated with Edoxaban up to 4 years. Furthermore, subgroup analyses will be performed in predefined patient populations, such as patients with renal or hepatic impairment.	—

Measure

Time frame

The primary objective of this study is to collect real-world safety data on bleeding events including intracranial haemorrhage, drug related adverse events such as liver adverse events, cardiovascular (CV) and all-cause mortality in AF patients treated with Edoxaban up to 4 years. Furthermore, subgroup analyses will be performed in predefined patient populations, such as patients with renal or hepatic impairment.

—

Secondary

Measure	Time frame
To assess the effect of Edoxaban on patient relevant outcomes as strokes, systemic embolic events, major cardiovascular (CV) events, hospitalisations related to CV condition, persistence to therapy, patient/physician reported outcome, health care utilization, resource use	—

Countries

Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom

Contacts

Public ContactPetra Laeis

Daiichi Sankyo Europe GmbH

petra.laeis@daiichi-sankyo.eu+49 89 7808-614

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026