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

NCT ID: NCT02876718

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

253 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-11

Study Completion Date

2018-01-09

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Rivaroxaban (Xarelto, BAY 59-7939)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations

Multiple Locations, , Taiwan

Site Status

Countries

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Taiwan

Related Links

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https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products.

Other Identifiers

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18728

Identifier Type: -

Identifier Source: org_study_id