check_circleStudy Completed
Atrial Fibrillation
Bayer Identifier:
18377
ClinicalTrials.gov Identifier:
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.
VKA (Waran®) will be compared to Rivaroxaban.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
382Trial Dates
February 2016 - February 2017Phase
N/ACould I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 patientenhanced_encryptionNoSafety Issue:
- 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 patientenhanced_encryptionNoSafety Issue:
- 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 patientenhanced_encryptionNoSafety Issue:
- 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 patientenhanced_encryptionNoSafety Issue:
- 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 patientenhanced_encryptionNoSafety Issue:
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:Baselineenhanced_encryptionNoSafety Issue:
- Patient’s quality of life measured using the SF-12 (interview version)Variables: Physical/psychological domain according to SF-12 questionnairedate_rangeTime Frame:up to 4 weeks after enrollment of patientenhanced_encryptionNoSafety Issue:
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: Agedate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: Genderdate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: preferred Anticoagulation treatment (agent)date_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 scoredate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRAdate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)date_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: Lifestyle variablesdate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: Previous switch of anticoagulation treatmentdate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A