Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients with Venous Thromboembolism in Europe

Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients with Venous Thromboembolism in Europe - ETNA-VTE-Europe

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00007934

Enrollment

2700

Registered

2015-07-30

Start date

2015-08-26

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA - 10066899: Venous thromboembolism I82

Interventions

Group 1: - Patients from different countries and care settings (primary and secondary care and different specialties) with acute venous thromboembolism (VTE) treated with Edoxaban according to the sum

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Established acute initial or recurrent VTE - 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 As this is a non-interventional study, no additional selection criteria apply. Patients will only be included in the study after the treating physician has made the clinical decision to prescribe Edoxaban. The prescription behavior will not be influenced.

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
Primary objective is the analysis of the overall symptomatic VTE recurrence rate during an overall observational period of 18 months in unselected patients with acute VTE. The co-primary objective of this study is to collect real world safety data on bleeding events, drug related adverse events such as liver adverse events, and mortality (VTE-related and all-cause) in patients treated with edoxaban. Furthermore, safety analyses in pre-specified subpopulations such as patients with renal impairment and patients with hepatic impairment will be performed.	—

Measure

Time frame

Primary objective is the analysis of the overall symptomatic VTE recurrence rate during an overall observational period of 18 months in unselected patients with acute VTE. The co-primary objective of this study is to collect real world safety data on bleeding events, drug related adverse events such as liver adverse events, and mortality (VTE-related and all-cause) in patients treated with edoxaban. Furthermore, safety analyses in pre-specified subpopulations such as patients with renal impairment and patients with hepatic impairment will be performed.

—

Secondary

Measure	Time frame
To assess the effect of edoxaban on relevant patient outcomes as recurrence rate of symptomatic VTE during edoxaban treatment, recurrence rate of symptomatic VTE after cessation of edoxaban treatment, hospitalisations, post-thrombotic syndrome, persistence to therapy, patient/physician reported outcomes, health care utilization, resource use	—

Countries

Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom

Contacts

Public ContactPetra Laeis

Daiichi Sankyo Europe GmbH

petra.laeis@daiichi-sankyo.eu+49 89 7808-614

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026