Xarelto Evidence in Real Life of Patients Preference and Satisfaction Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 253
- Locations
- 1
- Primary Endpoint
- Patient preferences for anticoagulant treatment attributes (utility values obtained in Logit/Probit estimates)
Study Overview
Brief Summary
The main objective of the study is to assess preferences of Non Valvular Atrial Fibrillation (NVAF) patients towards different options of an anticoagulation treatment.
Patient preferences for anticoagulant treatment attributes (convenience attributes only), based on a Discrete Choice Experiment(DCE) interview will be elicited and the impact of switching from Vitamin K Antagonist(VKA) to Xarelto® on Atrial Fibrilation(AF) patient treatment satisfaction will be documented, measured by score differences of the Anti-Clot Treatment Scale (ACTS) score in patients switching from VKA to Rivaroxaban.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female and male patients ≥ 20 years of age (legal age limit in Taiwan) with a confirmed diagnosis of AF (non-valvular).
- •Treatment with VKA for at least 6 weeks.
- •Decision to initiate treatment with Rivaroxaban has been made as per investigator's routine treatment practice.
- •Written informed consent of the patient.
- •Wilingness and capability to conduct two F2F interviews.
Exclusion Criteria
- •Contraindications to the use of Rivaroxaban as outlined in the local product information .
- •Concomitant treatment with any other anticoagulants.
- •Participation in another study (clinical intervention/observational) within the 3 months prior to enrollment.
- •Patients participating in an investigational program with interventions outside of routine clinical practice.
Arms & Interventions
Rivaroxaban, BAY59-7939
It is a single-arm study in which only patients who switched from a VKA to a NOAC treatment will be included.
Intervention: Rivaroxaban (Xarelto, BAY 59-7939) (Drug)
Outcomes
Primary Outcomes
Patient preferences for anticoagulant treatment attributes (utility values obtained in Logit/Probit estimates)
Time Frame: At 3 months
The preferred attributes will be assessed by a questionnaire following a discrete choice experimental design.
Secondary Outcomes
- Change of the Anti-clot treatment scale (ACTS) benefit and burden score from baseline (on VKA) to 3 months (on Xarelto)(At 0 month and at 3 months)
- Reasons for switch from VKA to Xarelto(At 0 month)
- AF symptoms as measured by European Heart Rhythm Association (EHRA) symtoms (both severity and frequency)(At 3 months)