Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe (ETNA-VTE)

Daiichi Sankyo

Status: Completed

Conditions: Venous Thromboembolism

Treatments: Drug: Edoxaban

Study type: Observational

Funder types: Industry

Identifiers

NCT02943993

DSE-EDO-05-14-EU

Details and patient eligibility

About

According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months (Hokusai-VTE; N Engl J Med. 2013; 369:1406-15).

Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 18 months in an unselected patient population in routine clinical practice.

Full description

Real-world evidence data in routine clinical practice use of edoxaban up to 18 months will be collected in 2,700 patients, treated by specialized as well as non-specialized physicians in hospitals and office based centres in 8 European countries. Patients from different countries and care settings (primary care and secondary care, different specialties) will be enrolled in this post-authorization safety study. Documentation of baseline and follow up information at 1, 3, 6, 12, and 18 months (only when available) will be collected. In addition, recurrence of symptomatic VTE and death will be captured retrospectively at time point of Last Patient Out per country.

Patients who discontinue permanently edoxaban during the observational period will be followed up according to the same scheme.

Enrollment: 2,809 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Established acute initial or recurrent VTE
• Clinical decision for treatment with edoxaban is made at the time of enrollment
• Written informed consent for participation in the study (ICF)
• Not simultaneously participating in any interventional study

Exclusion criteria

• None

Trial design

2,809 participants in 1 patient group

Patients treated with Edoxaban

Description:

Patients with established initial or recurrent acute symptomatic VTE treated with edoxaban according to the 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.

Treatment:

Drug: Edoxaban