Real-world Study on Edoxaban Treatment for Patients With Non-valvular Atrial Fibrillation in China (ETNA-AF-CHINA)
Status
Conditions
Treatments
Details and patient eligibility
About
The safety of edoxaban treatment will be examined using real-world clinical evidence from adult patients with non-valvular atrial fibrillation (NVAF) indications in routine clinical practice.
Full description
This non-interventional, observational study will evaluate the safety of edoxaban treatment in adult patients with NVAF indications with one or more risk factors.
The primary objective of the study is to collect and evaluate safety data up to 2 years in a real-world setting in relation to adverse event onset (related to edoxaban treatment), duration, severity, and outcome.
The secondary objective will evaluate the effect of edoxaban treatment on stroke (ischemic and hemorrhagic), systemic embolic event (SEE), transient ischemic attack (TIA), major adverse cardiovascular events (MACE), venous thromboembolism (VTE), acute coronary syndrome (ACS), hospitalization related to cardiovascular condition, extent of exposure and compliance to edoxaban therapy, and rate and reasons of permanent discontinuation of edoxaban therapy.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Written, informed consent
- NVAF-patients treated with edoxaban according to packaging information (i.e., for NVAF adult patients with one or more risk factors (such as history of congestive heart failure, hypertension, age ≥75 years old, diabetes, prior stroke or TIA) in prevention of stroke and systemic circulation embolism)
- Not participating in any interventional study at the same time
Exclusion criteria
- Not applicable
Trial design
5,000 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Contact for Clinical Trial Information
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal