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Completed

NCT Number: NCT02943993

Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

International Clinical Research GmbH

Germering, 82110, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edoxaban

Drug

Prescribed according to approved label

Other names: Lixiana

Primary outcomes

  1. Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall

    Time frame: Baseline up to end of observation period (18 months)

    Descriptive statistics were used to report the number of participants with at least 1 symptomatic VTE recurrence. Recurrent VTE events were based on adjudicated events.

    For the overall symptomatic VTE, precentage of participants (including 95% confidence intervals) were calculated.

  2. Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment

    Time frame: Baseline up to end of observation period (18 months)

    Descriptive statistics were used to report the number of participants with bleeding events.

    For the analysis of bleeding events, absolute number of participants were calculated.

Secondary outcomes

  1. Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall

    Time frame: Baseline up to end of observation period (18 months)

    Descriptive statistics were used to report the number of participants experiencing recurrent VTE and at least 1 real world safety event. VTE recurrence data were reported by recurrent deep vein thrombosis (DVT), recurrent pulmonary embolism (PE) with DVT, and recurrent PE only. Recurrent VTE events were based on adjudicated events. Real world safety events included all-cause death, cardiovascular (CV)-related death, VTE-related death, stroke, systemic embolic event, and hospitalization related to CV.

    For recurrent VTE and real world safety events, absolute and relative frequencies (including 95% confidence intervals) were calculated.

  2. Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment

    Time frame: Baseline up to end of observation period (18 months)

    Descriptive statistics were used to report the number of participants with overall symptomatic VTE recurrence. VTE recurrence data were further reported by recurrent deep venous thrombosis (DVT), recurrent pulmonary embolism (PE) with deep venous thrombosis (DVT), and recurrent PE only. Recurrent VTE events were based on adjudicated events.

    For symptomatic VTE recurrence, percentage of participants (95% confidence intervals) were calculated.

  3. Total Number of Venous Thromboembolism Recurrences By Type - Overall

    Time frame: Baseline up to end of observation period (18 months)

    Descriptive statistics were used to describe the number of VTE events reported by the patient.

    For VTE recurrences, absolute number of VTE events were calculated.

  4. Duration of Venous Thromboembolism Recurrences, by Type - Overall

    Time frame: Baseline up to end of observation period (18 months)

    Descriptive statistics were used to assess the duration of VTE events reported by the patient.

    For VTE recurrences, median duration of VTE events (interquartile range) were calculated.

  5. Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment)

    Time frame: Baseline up to end of observation period (18 months)

    Descriptive statistics were used to assess the number of recurrent VTE events reported by the patient.

    For VTE recurrences, absolute number of VTE recurrences were calculated.

  6. Duration of Venous Thromboembolism Events (On Edoxaban Treatment)

    Time frame: Baseline up to end of observation period (18 months)

    Descriptive statistics were used to assess the duration of VTE events reported by the patient.

    For VTE events, median duration of VTE events (interquartile range) were calculated.

  7. Number of Participants With Risk Factors for Thromboembolic Events at Baseline

    Time frame: at Baseline

    Descriptive statistics were used to assess the number of participants with risk factors for thromboembolic events.

    For risk factors for thromboembolic events, absolute number of participants with risk factors (percentage) were calculated.

  8. Duration of Edoxaban Treatment

    Time frame: Baseline up to end of observational period (18 months)

    Descriptive statistics were used to report the duration of edoxaban treatment.

  9. Number of Stroke Events

    Time frame: Baseline up to end of observation period (18 months)

    Descriptive statistics were used to report the number of stroke events.

    For stroke events, absolute number of stroke events were calculated.

  10. Number of Systemic Embolic Events - Overall

    Time frame: Baseline up to end of observation period (18 months)

    Descriptive statistics were used to report the number of systemic embolic events (SEE).

    For SEE, absolute SEEs were calculated.

  11. Overview of Participants With Adverse Drug Reactions

    Time frame: Baseline up to end of observation period (18 months)

    Descriptive statistics were used to report an overview of participants with adverse drug reactions (ADR). ADRs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.

  12. Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)

    Time frame: Baseline up to end of observational period (18 months)

    Adverse drug reactions were reported and coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.

  13. Number of Participants With Pre-defined Adverse Drug Reactions

    Time frame: Baseline up to end of observation period (18 months)

    Descriptive statistics were used to report the number of participants with pre-defined adverse drug reactions (ADR). ADRs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Industry

Registry information

Official study title

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

Acronym: ETNA-VTE

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2016
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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