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

Completed

• Conditions: MedDRA - 10003658: Atrial fibrillation; I48; Atrial fibrillation and flutter

• Registration Number: DRKS00007912
• Lead Sponsor: Daiichi Sankyo Europe GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-30
• Study Completion: 2018-08-12
• Results First Posted: 2023-11-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 13980

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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<br>