Non-interventional study on Edoxaban treatment in routine clinical practice for patients with non valvular atrial fibrillation

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00007912
• Date of registration: 30/07/2015
• Prospective Registration: Yes
• Primary sponsor: Daiichi Sankyo Europe GmbH
• Public title: Non-interventional study on Edoxaban treatment in routine clinical practice for patients with non valvular atrial fibrillation
• Scientific title: Non-interventional study on Edoxaban treatment in routine clinical practice for patients with non valvular atrial fibrillation - ETNA-AF-Europe
• Date of first enrolment: 14/08/2015
• Target sample size: 13100
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00007912
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment

Countries of recruitment

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

Contacts

• Name: Petra Laeis
• Affiliation: Daiichi Sankyo Europe GmbH

• Name: Petra Laeis
• Affiliation: Daiichi Sankyo Europe GmbH

Key inclusion & exclusion 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: Not applicable

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

MedDRA - 10003658: Atrial fibrillation
I48

Atrial fibrillation and flutter

Intervention(s)

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 of Product Characteristics (SmPC)
- Number of recommended visits: 5 – Baseline (BL) plus one visit every 12 months, plus Edoxaban treatment discontinuation visit if applicable, plus final assessment
- Patients who permanently discontinue Edoxaban during the observation period will be followed-up annually as well

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

ENCEPP/SDPP/8896

DSE-EDO-04-14

Source(s) of Monetary Support

Daiichi Sankyo Europe GmbH

Ethics review

Status: Approved
Approval date: 17/04/2015
Contact:

[e-mail]

Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster

[phone]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00007912#studyResults