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

Atrial Fibrillation Clinical Trial

— X-PRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876718
• Other study ID #: 18728
• Status: Completed
• Start date: August 11, 2016
• Est. completion date: January 9, 2018

Study information

• Verified date: December 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: January 9, 2018
• Est. primary completion date: January 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Many Locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	AF symptoms as measured by European Heart Rhythm Association (EHRA) symtoms (both severity and frequency)		At 3 months
Secondary	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

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