Trial document




drksid header

  DRKS00011080

Trial Description

start of 1:1-Block title

Title

APAF Apixaban in Atrial Fibrillation Registry

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

APAF

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011080
  •   2016/09/21
  •   2015/09/21
  •   yes
  •   Approved
  •   837.279.15 (10047), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT02563639  (ClinicalTrials.gov)
  •   CV185-404  (IHF GmbH - Institut für Herzinfarktforschung)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Atrial Fibrillation
  •   I48.0 -  [generalization I48: Atrial fibrillation and flutter]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with atrial fibtrillation (new diagnosed, paroxysmal, permanent or persistent), 5000 patients, consecutive enrollment in the registry, oberservational period 12 months
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Comparison of antithrombotic therapy for atrial fibrillation: Prescribed drugs; time frame: 12 months; Name of antithrombotic drug

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- 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
- Quality of Life; time frame: 12 months; Questionnaire (EQ-5D-5L)
- Comparison of antithrombotic therapy for atrial fibrillation: Dose of drugs; time frame: 12 months; Dose of antithrombotic drug
- Comparison of antithrombotic therapy for atrial fibrillation: Duration of treatment; time frame: 12 months; Duration of treatment [months]
- Comparison of antithrombotic therapy for atrial fibrillation: Contraindications for anticoagulation; time frame: 12 months; Relative and absolute contraindications to anticoagulation at baseline and history
- Comparison of antithrombotic therapy for atrial fibrillation:Selection of anticoagulant; time frame: 12 months; Basis for the selection of the anticoagulant

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/09/30
  •   5000
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

No exclusion criteria

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • IHF GmbH - Institut für Herzinfarktforschung
    • Bremserstraße 79
    • 67063  Ludwigshafen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0621 503 2814
    •   [---]*
    •   frey at ihf.de
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinikum Ludwigshafen
    • Mr.  Prof. Dr.  Uwe  Zeymer 
    • Bremserstraße 79
    • 67063  Ludwigshafen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   0621 503 0
    •   [---]*
    •   frey at ihf.de
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • IHF GmbH
    • Mr.  Erich  König 
    • Bremserstraße 79
    • 67063  Ludwigshafen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • IHF GmbH
    • Bremserstraße 79
    • 67063  Ludwigshafen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2018/08/15
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.