Trial document




drksid header

  DRKS00007934

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ETNA-VTE-Europe

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This study is purely observational and will collect data from medical records of patients suffering from acute venous thromboembolism (i.e. deep vein thrombosis = a blood clot in arms or legs and/or a pulmonary embolism = ablood clot that broke lose and travelled to the lungs) treated with Lixiana® (Edoxaban). No additional examinations will be carried out for this study. The patients' medical treatment by their doctor will be performed according to routine clinical practice and will not be influenced. In this study, information regarding the recurrence rate of blood clots (venous thromboembolic events), the health of the participating patients, how well they tolerate Lixiana® and how it is used in routine clinical practice by the physicians. The study will be performed in 10 European countries and aims to enrol a total of approximately 2550 patients from 640 sites. During an initial visit, the physician will collect data for the study (baseline visit). Data will be collected again at routine office/clinic visits at 1, 3, 6, 12 and 18 months following this. In case no routine clinic visit is scheduled at these time points, the patients will be contacted by phone to get information about their health status. The phone calls will be done by their physician or qualified persons at a contract research organisation.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Edoxaban is an orally administered anticoagulant that inhibits coagulation factor Xa. It has recently been approved by the European Medicines Agency EMA for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, as well as for the treatment of adult patients with venous thromboembolism including deep vein thrombosis and/or pulmonary embolism (after initial heparin lead-in), and the prevention of recurrent VTE.
This study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events and other drug related adverse events) of the treatment with Edoxaban in an unselected patient population in routine clinical practice. Real worls evidence data of routine clinical practice use of Edoxaban up to 18 months will be collected in 2550 patients, treated by specialized as well as non-specialized physicians in hospitals and office based centres.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007934
  •   2015/07/30
  •   [---]*
  •   no
  •   Approved
  •   123-15, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   DSE-EDO-05-14-EU  (Studiennummer/Study No.)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I82 -  Other venous embolism and thrombosis
  •   10066899: Venous thromboembolism
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   - 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 summary of product characteristics (SmPC).
    - Recommended visits: Baseline plus follow-up visits after 1, 3, 6, 12 and 18 months including a final assessment.
    - Patients who permanently discontinue Edoxaban during the 18 months observation period will be followed up until the end of the observation period.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Belgium
  •   Germany
  •   France
  •   Ireland
  •   Italy
  •   Austria
  •   Portugal
  •   Switzerland
  •   Spain
  •   United Kingdom
  •   Netherlands
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/08/26
  •   2700
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Not applicable

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Daiichi Sankyo Europe GmbH
    • Zielstattstr. 48
    • 81379  München
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Daiichi Sankyo Europe GmbH
    • Ms.  Dr.  Petra  Laeis 
    • Zielstattstr. 48
    • 81379  München
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Daiichi Sankyo Europe GmbH
    • Ms.  Dr.  Petra  Laeis 
    • Zielstattstr. 48
    • 81379  München
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Daiichi Sankyo Europe GmbH
    • Zielstattstr. 48
    • 81379  München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.