check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

18377

ClinicalTrials.gov Identifier:

NCT02611635

EudraCT Number:

Not Available

EU CT Number:

Not Available
Atrial Fibrillation patient preference study

Trial purpose

The main research question of this patient survey is to assess AF patients’ preferences associated with different attributes which describe the different available anticoagulation treatment options (VKA or NOACs and, in case of NOACs, Apixaban, Dabigatran or Rivaroxaban).
VKA (Waran®) will be compared to Rivaroxaban.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • Inclusion criteria for AF patients in both the NOAC and the VKA groups:
    - Patients with a confirmed diagnosis of nonvalvular atrial fibrillation (persistent, paroxysmal, permanent),
    - Age of at least 18 years at time of study inclusion,
    - Generally willingness (informed consent) and ability to fill out a survey on satisfaction with treatment and quality of life, and to conduct a structured phone interview (approx. 20 - 30 min) in Swedish language.

    Additional inclusion criterion for Group 1 (NOAC):
    - Continuous anticoagulation with either Apixaban, or Dabigatran or Rivaroxaban for prevention of Stroke & systemic embolism for at least the previous 3 months.

    Additional inclusion criterion for Group 2 (VKA):
    - Continuous anticoagulation with a VKA for prevention of Stroke & systemic embolism for at least the previous 3 months.


  • Exclusion criteria for both groups:
    - Participation in another

Trial summary

Enrollment Goal
382
Trial Dates
February 2016 - February 2017
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Sweden

Primary Outcome

  • AF patients`preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Frequency of intake (once/twice daily)
    date_rangeTime Frame:
    up to 4 weeks after enrollment of patient
    enhanced_encryption
    Safety Issue:
    No
  • AF patients`preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Need of International normalized ratio (INR) monitoring/dose adjustment (yes/no)
    date_rangeTime Frame:
    up to 4 weeks after enrollment of patient
    enhanced_encryption
    Safety Issue:
    No
  • AF patients`preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Need of bridging (yes/no)
    date_rangeTime Frame:
    up to 4 weeks after enrollment of patient
    enhanced_encryption
    Safety Issue:
    No
  • AF patients`preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Interactions with food/drugs (yes/no)
    date_rangeTime Frame:
    up to 4 weeks after enrollment of patient
    enhanced_encryption
    Safety Issue:
    No
  • AF patients`preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Distance to treating physician (1km or 50km).
    date_rangeTime Frame:
    up to 4 weeks after enrollment of patient
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Patient-related burden of treatment with anticoagulants measured by the Benefit and Burden Scale of the Anti-clot Treatment Scale (ACTS)
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Patient’s quality of life measured using the SF-12 (interview version)
    Variables: Physical/psychological domain according to SF-12 questionnaire
    date_rangeTime Frame:
    up to 4 weeks after enrollment of patient
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: Age
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: Gender
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: preferred Anticoagulation treatment (agent)
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 score
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRA
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: Lifestyle variables
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: Previous switch of anticoagulation treatment
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No

Trial design

AF patient preferences towards NOAC versus VKA treatment: a patient preference study.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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