Xarelto Evidence in Real Life of Patients' Preference and Satisfaction Study (X-PRESS)

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

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY 59-7939)

• Study Type: Observational
• Enrollment (Actual): 253

Contacts and Locations

Study Locations

• Taiwan
  • Multiple Locations, Taiwan
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 300 patients will be included in this study. Participating centers are either primary care practices, internal medicine specialist practices or out-patient sites/out-patient clinics

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Rivaroxaban (Xarelto, BAY 59-7939); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2016
• Primary Completion (Actual): January 9, 2018
• Study Completion (Actual): January 9, 2018

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimate): August 24, 2016

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 18728