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Apixaban in Atrial Fibrillation Registry (APAF)

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ClinicalTrials.gov Identifier: NCT02563639
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
IHF GmbH - Institut für Herzinfarktforschung

Brief Summary:
Objective of the registry is to assess the use of antithrombotic therapies and adherence to guidelines in patients with non-valvular atrial fibrillation.

Condition or disease
Atrial Fibrillation

Detailed Description:

Atrial fibrillation (AF) confers a substantial risk of mortality and morbidity from stroke and thromboembolism, and this common cardiac arrhythmia represents a major healthcare burden in Europe. Stroke prevention is central to the management of AF patients, with oral anticoagulation (OAC) using well-controlled adjusted dose vitamin K antagonists or novel OACs being recommended for patients with AF with ≥1 stroke risk factors. Also, the 2012 focused update of the ESC guidelines strongly advocates a clinical practice shift so that the initial decision step now is the identification of 'truly low risk' patients, essentially those age<65 without any stroke risk factors (both male and female), who do not need any antithrombotic therapy. The ESC guidelines only recommend use of the CHA2DS2-VASc score for stroke risk assessment, and the 'low risk' patients are defined as those with a CHA2DS2-VASc score=0 (males) or score=1 (females). Subsequent to this initial step of identifying the low risk patients, effective stroke prevention (which is essentially OAC) can then be offered to AF patients with ≥1 stroke risk factors, with treatment decisions made in consultation with patients and incorporating their preferences. Despite these recommendations, a substantial number of patients with AF is not treated with OAC. On the other hand, patients with AF and low risk are being "overtreated", receiving OAC despite a CHADS-VASc score of 0. Therefore, this registry will determine, if patients with non-valvular AF are treated ac-cording to current guidelines.

Apixaban is an oral factor Xa inhibitor, which has been tested in a number of indications. In the AVERROES study in patients with non-valvular atrial fibrillation deemed not suitable for treatment with a vitamin-K antagonist apixaban compared to aspirin reduced the incidence of stroke and systemic embolism without increasing bleeding complications. In the large ARISTOTELE study apixaban was superior to warfarin, it re-duced the primary endpoint of stroke and systemic embolism caused less bleeding and reduced all-cause mortality. Subsequently apixaban has been approved by the European health authorities for the use in patients with atrial fibrillation. It is therefore of interest to determine use of apixaban in real life with respect to patient selection, adherence to therapy and midterm efficacy and safety.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 5015 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: APAF Apixaban in Atrial Fibrillation Registry
Actual Study Start Date : September 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Comparison of antithrombotic therapy for atrial fibrillation: Prescribed drugs [ Time Frame: 12 months ]
    Name of antithrombotic drug


Secondary Outcome Measures :
  1. Safety of Apixaban as assessed by MACCE, Haemorrhagic complications, Ischemic clinical events, Stroke, Systemic embolism, Hospitalisations for stroke, cardiac reasons or bleeding complications [ Time Frame: 12 months ]
    • MACCE (death / MI / stroke)
    • Haemorrhagic complications (major / minor bleeding)
    • Ischemic clinical events (non-fatal MI, cardiac death, etc.)
    • Stroke (ischemic, haemorrhagic)
    • Systemic embolism
    • Hospitalisations for stroke, cardiac reasons or bleeding complications

  2. Subjective Quality of Life [ Time Frame: 12 months ]
    Questionnaire (EQ-5D-5L)

  3. Comparison of antithrombotic therapy for atrial fibrillation: Dose of drugs [ Time Frame: 12 months ]
    Dose of antithrombotic drug

  4. Comparison of antithrombotic therapy for atrial fibrillation: Duration of treatment [ Time Frame: 12 months ]
    Duration of treatment [months]

  5. Comparison of antithrombotic therapy for atrial fibrillation: Contraindications for anticoagulation [ Time Frame: 12 months ]
    Relative and absolute contraindications to anticoagulation at baseline and history

  6. Comparison of antithrombotic therapy for atrial fibrillation:Selection of anticoagulant [ Time Frame: 12 months ]
    Basis for the selection of the anticoagulant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-valvular atrial fibrillation (newly diagnosed, paroxysmal, permanent or persistent)
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Non-valvular atrial fibrillation
  • In hospitals or specialized or non-specialised office-based centres
  • Written informed consent for participation in observational study (incl. telephone follow-ups)
  • Not simultaneously participating in any randomized trial

Exclusion Criteria: No exclusion criteria


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563639


Locations
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Germany
Klinikum Ludwigshafen
Ludwigshafen, Germany, D-67063
Sponsors and Collaborators
IHF GmbH - Institut für Herzinfarktforschung
Bristol-Myers Squibb
Investigators
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Principal Investigator: Uwe Zeymer, Prof. Dr. Klinikum Ludwigshafen
Additional Information:

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Responsible Party: IHF GmbH - Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT02563639    
Other Study ID Numbers: CV185-404
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Keywords provided by IHF GmbH - Institut für Herzinfarktforschung:
newly diagnosed
paroxysmal
persistent
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes