Atrial Fibrillation
Conditions
Keywords
Non valvular Atrial Fibrillation, Non-interventional Study, Efficacy/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 non-interventional study to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) and efficacy of edoxaban use in non-preselected patients with NVAF.
Detailed description
Edoxaban was approved by the Ministry of Food and Drug Safety (MFDS) in Korea (date: 25th, August 2015) for the reduction in the risk of stroke and systemic embolism in patients with NVAF, treatment of deep vein thrombosis (DVT) and pulmonary embolism. Edoxaban was approved by the Taiwan Food and Drug Administration (TFDA) in Taiwan (date: 24th, February, 2016) for the prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age at least 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA), or treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), following 5 to 10 days of initial therapy with a parenteral anticoagulant. Real world evidence data of routine clinical practice use of edoxaban up to two years will be collected and evaluated in approximately 2,500 patients, treated by specialized as well as non-specialized physicians in hospital centers.
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 |
|---|---|---|
| Rate of Participants Experiencing Real-World Safety Data Events within 2 Years | within 2 years | Real-world safety data events include bleeding events (including intracranial haemorrhage), adverse events and mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participants with Patient Relevant Outcomes | within 2 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 cardiovascular (CV) condition. |
| Rate of Participants Compliant with Edoxaban Therapy | 2 years | Categories: Always, Almost Always, Most of the Time, Less than Half the Time, Unknown |
Countries
South Korea, Taiwan
Outcome results
None listed