NCT02876718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

August 11, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2018

Completed
Last Updated

December 24, 2018

Status Verified

December 1, 2018

Enrollment Period

1.4 years

First QC Date

July 22, 2016

Last Update Submit

December 21, 2018

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 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

    At 0 month

Study Arms (1)

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)

Interventions

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.

Rivaroxaban, BAY59-7939

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many Locations

Multiple Locations, Taiwan

Location

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2016

First Posted

August 24, 2016

Study Start

August 11, 2016

Primary Completion

January 9, 2018

Study Completion

January 9, 2018

Last Updated

December 24, 2018

Record last verified: 2018-12

Locations

TW(1)