Trial Condition(s):
Atrial Fibrillation
Atrial Fibrillation patient preference study (PRiSMA-AF)
Bayer Identifier:
18377
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
Inclusion Criteria
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
Exclusion criteria for both groups: - Participation in another
Trial Summary
Enrollment Goal
382
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Sweden | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
2
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)Timeframe: up to 4 weeks after enrollment of patient
- 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)Timeframe: up to 4 weeks after enrollment of patient
- 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)Timeframe: up to 4 weeks after enrollment of patient
- 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)Timeframe: up to 4 weeks after enrollment of patient
- 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).Timeframe: up to 4 weeks after enrollment of patient
Secondary Outcome
- Patient-related burden of treatment with anticoagulants measured by the Benefit and Burden Scale of the Anti-clot Treatment Scale (ACTS)Timeframe: Baseline
- Patient’s quality of life measured using the SF-12 (interview version)Variables: Physical/psychological domain according to SF-12 questionnaireTimeframe: up to 4 weeks after enrollment of patient
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: AgeTimeframe: Baseline
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: GenderTimeframe: Baseline
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: preferred Anticoagulation treatment (agent)Timeframe: Baseline
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 scoreTimeframe: Baseline
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRATimeframe: Baseline
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)Timeframe: Baseline
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: Lifestyle variablesTimeframe: Baseline
- Assessment of factors that may be associated with AF patients’ preferences towards a specific anticoagulation treatment: Previous switch of anticoagulation treatmentTimeframe: Baseline
Additional Information
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