Trial Condition(s):
Atrial Fibrillation
Anticoagulation preference by AF patients study (PRiSMA-AF)
Bayer Identifier:
18242
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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 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
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Switzerland | Status Completed | 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:
Other
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- 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).Timeframe: up to 4 weeks
Secondary Outcome
- Burden associated with anticoagulation treatment measured by the questionnaire ACTSTimeframe: Baseline
- Health-related quality of life measured by the SF-12 questionnaireVariables: Physical/psychological domain according to SF-12 questionnaireTimeframe: up to 4 weeks
- Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: preferred anticoagulation treatment (agent)Timeframe: up to 4 weeks
- Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 scoreTimeframe: up to 4 weeks
- Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRATimeframe: up to 4 weeks
- Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)Timeframe: up to 4 weeks
- Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: AgeTimeframe: up to 4 weeks
- Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: GenderTimeframe: up to 4 weeks
Additional Information
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