Trial document





This trial has been registered retrospectively.
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  DRKS00010926

Trial Description

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Title

EMIT-AF/VTE: Edoxaban management in diagnostic and therapeutic procedures

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Trial Acronym

EMIT-AF/VTE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Edoxaban is an anticoagulant used for stroke prevention in patients with atrial fibrillation and for prevention of thombosis in patients suffering from pulmonary embolism or deep vein thrombosis. The aim of this study is to look at the management of edoxaban in patients during diagnostic and therapeutic procedures and to collect safety information on any bleeding or cardiovascular events that occur within 30 days of the procedure.

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Brief Summary in Scientific Language

The primary objective of this registry is to document the periprocedural management of edoxaban in unselected patients and collect data on safety and other outcome in these patients

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Organizational Data

  •   DRKS00010926
  •   2017/08/07
  •   [---]*
  •   no
  •   Approved
  •   EA1/301/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   ATRIAL FIBRILLATION
  •   deep vein thrombosis
  •   pulmonary embolism
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Interventions/Observational Groups

  •   Patients already taking edoxaban who have a diagnostic or therapeutic procedure will have a follow up phone call 30 days after having a procedure to see if they had any bleeding or cardiovascular events in this time. Data relating to the procedure, the edoxaban usage and any bleeding/cardiovascular events will be collected in a database.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Any bleeding event the patient experiences within 30 days of the procedure will be collected. This will be done by a phone call. The bleeding events are categorised according to ISTH (International Society on Thrombosis and Haemostasis) standards.

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Secondary Outcome

Any cardiovascular event the patient experiences within 30 days of the procedure will be collected. This will be done by a follow up phone call to the patient.

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Countries of Recruitment

  •   Germany
  •   United Kingdom
  •   Italy
  •   Spain
  •   Netherlands
  •   Belgium
  •   Portugal
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/01/20
  •   2000
  •   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

• Patients taking edoxaban for a therapeutic indication according to the SmPC (NVAF, VTE including DVT and PE)
• Paients with a planned or unplanned diagnostic or interventional procedure
• Age ≥ 18 years
• Written informed consent
• Availability of patients for follow-up by telephone
• No concurrent participation in an interventional study

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Exclusion Criteria

N/A

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Addresses

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    • Daiichi Sankyo
    • Ms.  Dr.  Petra  Laeis 
    • Zeilstattstr. 48
    • 81379  Munich
    • Germany
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    • Daiichi Sankyo
    • Ms.  Dr.  Petra  Laeis 
    • Zeilstattstr. 48
    • 81379  Munich
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Daiichi Sankyo
    • Ms.  Dr.  Petra  Laeis 
    • Zeilstattstr. 48
    • 81379  Munich
    • Germany
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Sources of Monetary or Material Support

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    • Daiichi Sankyo
    • Ms.  Dr.  Petra  Laeis 
    • Zeilstattstr. 48
    • 81379  Munich
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/07/26
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.