check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:
18242
ClinicalTrials.gov Identifier:
NCT02607371
EudraCT Number:
Not Available
EU CT Number:
Not Available
Anticoagulation preference by AF patients study

Trial purpose

The main research question of this patient survey is to assess AF (Atrial Fibrillation) patients’ preferences associated with different attributes which describe the different available anticoagulation treatment options (Vitamin K Antagonists [VKA] or New Oral Anticoagulants [NOACs] and, in case of NOACs, Apixaban, Dabigatran, Edoxaban or Rivaroxaban).
VKAs (Marcoumar®, Sintrom ®) will be grouped together and 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 German 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 study (clinical intervention / observational) within the 3 months prior to enrollment,
    - Interruption of VKA/NOAC therapy of more than 2 weeks (bridging) within the prior 3 months or planned bridging in 4 weeks after study inclusion.

Trial summary

Enrollment Goal
198
Trial Dates
August 2015 - October 2016
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Switzerland

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
    - DCE is based on the following attributes /attribute levels: - Frequency of intake (once/twice daily), - Need of INR monitoring/dose adjustment (yes/no), - Need of bridging (yes/no), - Interactions with food/drugs (yes/no), - Distance to treating physician (1km or 15km).
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Burden associated with anticoagulation treatment measured by the questionnaire ACTS
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Health-related quality of life measured by the SF-12 questionnaire
    Variables: Physical/psychological domain according to SF-12 questionnaire
    date_rangeTime Frame:
    up to 4 weeks
    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:
    up to 4 weeks
    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:
    up to 4 weeks
    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:
    up to 4 weeks
    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:
    up to 4 weeks
    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:
    up to 4 weeks
    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:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

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

Additional Information

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