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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02876718
Acronym
X-PRESS
Enrollment
253
Registered
2016-08-24
Start date
2016-08-11
Completion date
2018-01-09
Last updated
2018-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

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.

Sponsors

Janssen Research & Development, LLC
CollaboratorINDUSTRY
Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Patient preferences for anticoagulant treatment attributes (utility values obtained in Logit/Probit estimates)At 3 monthsThe preferred attributes will be assessed by a questionnaire following a discrete choice experimental design.

Secondary

MeasureTime frameDescription
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 monthsACTS = Anti Clot treatment Scale is a questionnaire of 17 items (13 items on burden of treatment and 4 items on the benefits of treatment)
AF symptoms as measured by European Heart Rhythm Association (EHRA) symtoms (both severity and frequency)At 3 months
Reasons for switch from VKA to XareltoAt 0 monthThe reasons are selected by the participant out of a qualitative list of reasons for switch from VKA to Xarelto.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026