check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

18728

ClinicalTrials.gov Identifier:

NCT02876718

EudraCT Number:

Not Available

EU CT Number:

Not Available
Xarelto Evidence in Real Life of Patients’ Preference and Satisfaction Study

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

20 - N/A
  • - 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.


  • - 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.

Trial summary

Enrollment Goal
253
Trial Dates
August 2016 - January 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Taiwan

Primary Outcome

  • 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.
    date_rangeTime Frame:
    At 3 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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)
    date_rangeTime Frame:
    At 0 month and at 3 months
    enhanced_encryption
    Safety Issue:
    No
  • AF symptoms as measured by European Heart Rhythm Association (EHRA) symtoms (both severity and frequency)
    date_rangeTime Frame:
    At 3 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 0 month
    enhanced_encryption
    Safety Issue:
    No

Trial design

Xarelto Evidence in Real Life of Patients Preference and Satisfaction Study.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.