Trial document




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  DRKS00005996

Trial Description

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Title

European Multinational Prolongation Registry on Prevention of Thromboembolic Events in Atrial Fibrillation

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Trial Acronym

Prolongation PREFER in AF Registry

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URL of the Trial

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Brief Summary in Lay Language

This study is a prolongation of the already completed register study for the prevention of thromboembolic events in atrial fibrillation. Aim of the oberservation 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 thromoembolic events (i.e. formation of a clot in a blood vessel (thrombus) that breaks lose 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

Prolongation of the currently ongoing Multinational Registry on Prevention of Thromboembolic Events in Atrial Fibrillation (PREFER in AF) to gain further insight into the long-term management of patients with AF, with special focus on the use of new oral anticoagulants (NOACs). In the PREFER in AF registry a large patient population is observed and data on different anticoagulation treatment patterns are collected.
The aim of this registry is to prolong the patient observation period and recruit new patients to gain further insights into the long-term use of NOACs, including switching from Vitamin K antagonists (VKAs), to NOACs in a real life setting. This will include the collection of data on direct healthcare resource use and estimated costs correlated in patients with AF.

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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

  •   DRKS00005996
  •   2014/05/22
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  •   no
  •   Approved
  •   14026, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  •   DSE-EAF-01-13 
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Health Condition or Problem studied

  •   I48 -  Atrial fibrillation and flutter
  •   10003658 Atrial fibrillation
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Interventions/Observational Groups

  •  
    - only patients treated with NOAC or VKA;
    - Description of charakteristics 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 (visit1);
    - 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 itensity, frequencies and resource use for pharmaco-economic analyses.
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Characteristics

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

To describe the long-term use of NOACs and corresponding prescription patterns, including reasons for switching from VKAs to NOACs.

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Secondary Outcome

To gain insight on the long-term management of patients with atrial fibrillation (AF), treated with either NOACs or VKAs, with focus on the prevention of thromboembolic events.
To assess selected complications related to oral anticoagulants prescribed in AF, in particular bleeding.
To explore the relationship between anticoagulants and duration of therapy, adherence to therapy, resource utilization, estimated costs, treatment satisfaction, and health related quality of life, and clinical outcomes.

All the above mentioned objectives will be measured one year after baseline visit via a EQ-5D-5L and PACT-Q2. Also diaries will be distributed to the patients to record their contact with physician, nurse or other facilities throughout the year.

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Countries of Recruitment

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

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

  •   Actual
  •   2014/06/25
  •   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

-At least 18 years of age;
-Written informed consent for participation in the registry;
-History of non-valvular AF documented by electrical tracing (ECG, holter, pacemaker, implantable cardioverter defibrillator) within the prior 12 months;
-Treated with NOAC or VKA;

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Exclusion Criteria

Patients with mechanical valve replacements or moderate, moderately severe or severe mitral stenosis are not allowed to be enrolled.

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Addresses

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    • Daiichi Sankyo Europe GmbH
    • Zielstattstr. 48
    • 81379  München
    • Germany
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    • Daiichi Sankyo Europe GmbH, Clinical Operations
    • Ms.  Dr.  Petra  Laeis 
    • Zielstattstr. 48
    • 81379  München
    • Germany
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    • Daiichi-Sankyo Europe GmbH, Clinical Operations
    • Ms.  Dr.  Petra  Laeis 
    • 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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Status

  •   Recruiting complete, follow-up continuing
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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.