Trial document





This trial has been registered retrospectively.
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  DRKS00006862

Trial Description

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Title

Treatment with new oral anticoagulants in primary care practices

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

For decades drugs from the group of coumarins (eg warfarin) serve to prevent complications such as Stroke in atrial fibrillation. With the so-called New oral anticoagulants (Pradaxa, Xarelto, Eliquis) are first alternative drugs available.
According to the guideline of the German Society of General Practice and Family Medicine (DEGAM)
these are to be used primarily in patients who are not well-adjust with the usual therapy with coumarins. But what about the practice? For what reasons patients are transferred to these new oral anticoagulants? How effective was the coumarin therapy at the time of the change?
To find answers to these questions the present study investigates data from GP patients who have been prescribed in the past two years Pradaxa, Xarelto and Eliquis.

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Brief Summary in Scientific Language

For decades, vitamin K antagonists (VKA) from the group of coumarins serve to prevent cardioembolic complications in non-valvular atrial fibrillation. With the new oral anticoagulants Dabigatran (Pradaxa®), Rivaroxaban (Xarelto) and Apixaban (Eliquis®) are first alternatives available.
In the S1-guideline of the DEGAM (German Society of General Practice and Familiy Medicine) a change from a VKA to the new oral anticoagulants (NOAK) is not recommended for patients who can be easily treated with VKA.
If TTR (= time in therapeutic range, a measure of quality of coumarin therapy; describes the percentage of time being in the therapeutic INR range) is > 72.6%, it is assumed that the NOAK are not clinically superior to the VKA.
But what about the practice?
The present retrospective study will examine this issue, calculating the TTR value at the time of a change from VKA to NOAK.
Included are GP patients who have been prescribed in the past two years Pradaxa, Xarelto and Eliquis.
The aim is to verify the application of the guideline for NOAK.

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Organizational Data

  •   DRKS00006862
  •   2015/03/06
  •   [---]*
  •   yes
  •   Approved
  •   004/15, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   I48 -  Atrial fibrillation and flutter
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Interventions/Observational Groups

  •   non-interventional retrospective observational study.
    Documentation of medical records of GP patients who have been prescribed new oral anticoagulants (Dabigatran (Pradaxa®), Rivaroxaban (Xarelto) and Apixaban (Eliquis®)) in the last two years: Age, gender, medication, medical history, INR values, liver and kidney function.
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Characteristics

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

TTR at the time of a change from VKA to NOAK
(calculation with a formula including INR values)

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Secondary Outcome

Reason for the change of VKA to NOAK
(information from the electronic patient data or personal conversation with the concerned doctor)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/02/05
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

GP patients who have been prescribed in the past two years one of the drugs of Pradaxa, Xarelto and Eliquis

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Exclusion Criteria

Duration of warfarin-taking before changing to the new oral anticoagulants <6 months

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Addresses

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    • Universitätsklinikum Bonn
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Institut für Hausarztmedizin, Universitätsklinikum Bonn
    • Mr.  Prof. Dr. med.  Klaus  Weckbecker 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Institut für Hausarztmedizin, Universitätsklinikum Bonn
    • Ms.  Bettina  Weber 
    • Siegmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Hausarztmedizin, Universitätsklinikum Bonn
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/05/27
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Trial Publications, Results and other Documents

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