Xarelto Evidence in Real Life of Patients' Preference and Satisfaction Study

Study Overview
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Brief Summary
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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.

Official Title
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Xarelto Evidence in Real Life of Patients Preference and Satisfaction Study.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY 59-7939)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rivaroxaban, BAY59-7939<br>It is a single-arm study in which only patients who switched from a VKA to a NOAC treatment will be included. | Drug: Rivaroxaban (Xarelto, BAY 59-7939)<br>* No specified dosing or dosage in the study. The treatment decision falls within current practice and the prescription of the medicines is clearly separated from the decision to include the patient in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preferences for anticoagulant treatment attributes (utility values obtained in Logit/Probit estimates) | The preferred attributes will be assessed by a questionnaire following a discrete choice experimental design. | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Anti-clot treatment scale (ACTS) benefit and burden score from baseline (on VKA) to 3 months (on Xarelto) | ACTS = Anti Clot treatment Scale is a questionnaire of 17 items (13 items on burden of treatment and 4 items on the benefits of treatment) | At 0 month and at 3 months | 
| AF symptoms as measured by European Heart Rhythm Association (EHRA) symtoms (both severity and frequency) |  | At 3 months | 
| Reasons for switch from VKA to Xarelto | The reasons are selected by the participant out of a qualitative list of reasons for switch from VKA to Xarelto. | At 0 month |