Trial document




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  DRKS00003343

Trial Description

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Title

European Multinational Registry on Prevention of Thromboembolic Events in Atrial Fibrillation

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Trial Acronym

Prefer in AF

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Aim of the observation is to collect data of patients with atrial fibrillation (the most common cardiac arrhythmia) concerning their medical history, their concomitant diseases and their treatment with a focus on the prevention of thromboembolic events [i.e. formation of a clot in a blood vessel (thrombus) that breaks loose and is carried by the blood stream to plug another vessel in the lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or leg]

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Brief Summary in Scientific Language

Aim of the observation is to gain detailed insight on the characteristics and management of patients with atrial fibrillation with focus on prevention of thromboembolic events (in particular stroke).

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Organizational Data

  •   DRKS00003343
  •   2011/12/14
  •   [---]*
  •   no
  •   Approved
  •   Dossier no. 11.671, France - Ministère de l'Enseignement Supérieur et de la Recherche, Direction générale pour la recherche et l’innovation, Comité consultatif sur le traitement de l'information en matiére de recherche dans le domaine de la santé CCTIRS
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Secondary IDs

  •   DSE-EAF-01-11  (Daiichi Sankyo Study No.)
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Health Condition or Problem studied

  •   10003658 Atrial Fibrillation
  •   I48.19 -  [generalization I48: Atrial fibrillation and flutter]
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Interventions/Observational Groups

  •   • Description of characteristics of AF patients in terms of key (socio-)demographic data, risk factors, method of diagnosis, treatment modalities /
    • Retrospective documentation of events related to AF and anticoagulation therapy (within a 1 year period prior to inclusion) / • Assessment of quality of life at baseline (Visit 1) --- • Prospective observation of patients with atrial fibrillation / • Prospective collection of outcome data / • Prospective assessment of quality of life at 1 year / • Assessment of selected complications related to (oral) anticoagulants prescribed in AF, in particular bleeding / • Information on treatment intensity, frequencies and resource use for pharmaco-economic analyses

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Characteristics

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

Collection of data of subjects with atrial fibrillation regarding their medical history, their concomitant diseases and their treatment with a focus on the prevention of thromboembolic events.

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Secondary Outcome

Not applicable

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Countries of Recruitment

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

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Recruitment

  •   Actual
  •   2012/01/06
  •   5000
  •   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

Minimum age 18 years / Written informed consent for participation in the registry / History of Atrial Fibrillation documented by electrical tracing (ECG, Holter, pacemaker, implantable cardioverter defibrillator) within the prior 12 months

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Exclusion Criteria

None

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Addresses

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    • Daiichi Sankyo Europe GmbH
    • Zielstattstr. 48
    • 81379  München
    • Germany
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    •   [---]*
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    •   [---]*
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    • Daiichi Sankyo Europe GmbH, Clinical Operations
    • Ms.  Dr.  Tessa  Schliephacke 
    • Zielstattstr. 48
    • 81379  München
    • Germany
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    • Daiichi Sankyo Europe GmbH, Clinical Operations
    • Ms.  Dr.  Tessa  Schliephacke 
    • 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
  •   2014/01/29
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Trial Publications, Results and other Documents

  •   Europace. 2014 January; 16(1): 6–14. Published online 2013 October 1. doi: 10.1093/europace/eut263
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