Trial document





This trial has been registered retrospectively.
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  DRKS00004795

Trial Description

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Title

Prevention of Thromboembolic Events – European Registry in Venous Thromboembolism

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Trial Acronym

PREFER in VTE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this registry, it is intended to assess the characteristics and management of patients with venous thromboembolism and to assess health care resources and estimated costs in relation to this disease. This registry is purely observational and no additional examinations will be carried out. The patient's medical treatment by their doctor will not be influenced.

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Brief Summary in Scientific Language

This study is a prospective non-interventional study to assess the characteristics and management of patients with venous thromboembolism and the use of health care resources and the estimated costs for 12 months following confirmed first-time and/or recurrent venous thromboembolism diagnosis. In addition, existing anti-coagulant treatment patterns, patient pathways, clinical outcomes, treatment satisfaction, and health related quality of life in a naturalistic setting will be described.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004795
  •   2013/03/15
  •   [---]*
  •   no
  •   Approved
  •   837.553.12 (8654), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Venous Thromboembolism
  •   I82 -  Other venous embolism and thrombosis
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Interventions/Observational Groups

  •   - Patient characteristics
    - History of thromboembolic/bleeding events and diagnose of acute venous thromboembolism
    - Drug utiliation / use pattern of drugs for treatment of venous thromboembolism and prevention of related events
    - health related quality of life
    - resource consumption / Health Care Utilization
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health economics
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary objective of this study is to assess the 12 month direct healthcare resource use and estimated costs following acute first time (initial) or recurrent venous thromboembolism. In addition, detailed insight on the characteristics and management of patients with acute venous thromboembolism (in particular deep vein thrombosis and/or pulmonary embolism) with focus on prevention of related events (e. g. bleeding or other complications, recurrence of deep vein tmbosis/pulmonary embolism, myocardial infarction, stroke, systemic embolic event, post thrombotic syndrome, percutaneous coronary intervention, coronary artery bypass graft, and death) will be collected.

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Secondary Outcome

- To describe the treatment satisfaction (PACT Q2), health related quality of life (EQ 5D), and clinical outcomes following first time (initial) or recurrent venous thromboembolism. Timepoints: Baseline, 1, 3, 6 and 12 month(s) after baseline
- To explore relationship between anticoagulants and duration of therapy and resource use, estimated costs, treatment satisfaction (PACT Q), and health related quality of life (EQ D5), and clinical outcomes.
- To explore geographic variations in the management of patients with venous thromboembolism

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
  •   Italy
  •   Spain
  •   United Kingdom
  •   France
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Locations of Recruitment

  • Medical Center 
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  • University Medical Center 
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  • University Medical Center 
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  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/01/24
  •   4500
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Established acute initial or recurrent VTE
• In hospitals, surgical or non-surgical wards or specialised office-based centres
• Written informed consent for participation in the registry (including telephone follow-ups)
• Not simultaneously participating in a double blind interventional study

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Exclusion Criteria

No explicit medical exclusion criteria are stated

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Addresses

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    • Daiichi-Sankyo Europe GmbH
    • 81379  München
    • Germany
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    •   [---]*
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    • Daiichi Sankyo Europe GmbH
    • Mr.  Dr.  Wolf-Peter   Wolf 
    • Zielstattstraße 48
    • 81379  München
    • Germany
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    • Daiichi Sankyo Europe GmbH
    • Mr.  Dr.  Wolf-Peter  Wolf 
    • Zielstattstr. 48
    • 81379  München
    • Germany
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Sources of Monetary or Material Support

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    • Daiichi Sankyo Europe GmbH
    • Zielstattstr. 48
    • 81379  München
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/08/28
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* This entry means the parameter is not applicable or has not been set.