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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Edoxaban

• Registration Number: NCT02944019
• Lead Sponsor: Daiichi Sankyo

Brief 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).

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-25
• Primary Completion: 2022-04-13
• Study Completion: 2022-04-13
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Edoxaban	Edoxaban	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Real-World Safety Data Events within 4 Years	within 4 years	Real-world safety data events include bleeding events including intracranial haemorrhage, drug related adverse events such as liver adverse events, cardiovascular (CV) and all-cause mortality

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Patient Relevant Outcomes	within 4 years	Patient relevant outcomes include Strokes (ischaemic and haemorrhagic) , Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), and Hospitalisations related to a CV condition.
Percentage of Participants Compliant with Edoxaban Therapy	over 4 years	Categories: Always, Almost Always, Most of the Time, Less than Half the Time, Unknown

Trial Locations

Locations (723)

Wahlarzt Ordination, Dr. Paul Pinter, Altenmarkt; 🇦🇹 Altenmarkt, Austria

Krankenhaus St. Josef Braunau, Innere Medizin 2, Braunau; 🇦🇹 Braunau Am Inn, Austria

Landeskrankenhaus Feldkirch, Kardiologie, Feldkirch; 🇦🇹 Feldkirch, Austria

Universitaetsklinik Graz, Onkologie, Graz; 🇦🇹 Graz, Austria

KRAGES Burgenlaendische Krankenanstalten LH Guessing, Innere Medizin, Guessing; 🇦🇹 Guessing, Austria

Klinikum Klagenfurt, Kardiologie, Klagenfurt; 🇦🇹 Klagenfurt, Austria

A. Oe. Kh Der Barmherzigen Schwestern, Kardiologie, Linz; 🇦🇹 Linz, Austria

Kepler Universitaetsklinikum, Kardiologie, Linz; 🇦🇹 Linz, Austria

Krankenhaus der Elisabethinen Linz, Kardiologie, Linz; 🇦🇹 Linz, Austria

Kepler Universitätsklinikum, Neurologie, Linz; 🇦🇹 Linz, Austria

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