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Completed

NCT Number: NCT02876718

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivaroxaban (Xarelto, BAY 59-7939)

Drug

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.

Primary outcomes

  1. Patient preferences for anticoagulant treatment attributes (utility values obtained in Logit/Probit estimates)

    Time frame: At 3 months

    The preferred attributes will be assessed by a questionnaire following a discrete choice experimental design.

Secondary outcomes

  1. Change of the Anti-clot treatment scale (ACTS) benefit and burden score from baseline (on VKA) to 3 months (on Xarelto)

    Time frame: 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)

  2. AF symptoms as measured by European Heart Rhythm Association (EHRA) symtoms (both severity and frequency)

    Time frame: At 3 months

  3. Reasons for switch from VKA to Xarelto

    Time frame: At 0 month

    The reasons are selected by the participant out of a qualitative list of reasons for switch from VKA to Xarelto.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Acronym: X-PRESS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 24, 2016
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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