Atrial Fibrillation
Conditions
Keywords
Nonvalvular Atrial Fibrillation, Post Authorisation Safety Study, Safety, Real World Evidence
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).
Interventions
DRUGEdoxaban
Prescribed according to approved label
Sponsors
Daiichi Sankyo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Austria, Belgium, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom
Outcome results
None listed