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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (Xarelto, BAY 59-7939)

• Registration Number: NCT02876718
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-22
• Study Start: 2016-08-11
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-24
• Primary Completion: 2018-01-09
• Study Completion: 2018-01-09
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban, BAY59-7939	Rivaroxaban (Xarelto, BAY 59-7939)	It is a single-arm study in which only patients who switched from a VKA to a NOAC treatment will be included.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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)
Reasons for switch from VKA to Xarelto	At 0 month	The reasons are selected by the participant out of a qualitative list of reasons for switch from VKA to Xarelto.
AF symptoms as measured by European Heart Rhythm Association (EHRA) symtoms (both severity and frequency)	At 3 months

Trial Locations

Locations (1)

Many Locations; 🇨🇳 Multiple Locations, Taiwan