Xarelto [SPAF-QOL] Post-marketing Surveillance in Japan

May 28, 2019 updated by: Bayer

Treatment Satisfaction Under Rivaroxaban (ACTS/TSQM)

The objective of this study is to understand if Rivaroxaban can improve treatment satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real clinical practice.

A total of 725 patients are to be enrolled and followed for a 6 months.period. QOL survey will be conducted at month 0, 3, 6 using ACTS/TSQM.

This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

741

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Multiple Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with non-valvular atrial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism

Description

Inclusion Criteria:

  • Patients treated by Warfarin for their atrial fibrillation for at least two months at the time of the study initiation.
  • Rivaroxaban naïve patients
  • Patients 20 years old or older.
  • Patients who agree to sign the inform consent

Exclusion Criteria:

  • Patients who are contraindicated by product label

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Patients treated with Xarelto under practical manner for SPAF.
Drug: Rivaroxaban (Xarelto_ BAY59-7939)
Patients treated with Xarelto under practical manner for SPAF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires)
Time Frame: Up to 6 months
Up to 6 months
Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin)
Time Frame: Up to 6 months
Up to 6 months
Incidence of events of stroke
Time Frame: Up to 6 months
Up to 6 months
Incidence of events of non-central nervous system embolism
Time Frame: Up to 6 months
Up to 6 months

Other Outcome Measures

Outcome Measure
Time Frame
Treatment satisfaction scores at Month 3 and Month 6 by demographic and clinical characteristics
Time Frame: At Month 3 and Month 6
At Month 3 and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Scientific Affairs, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2012

Primary Completion (Actual)

June 9, 2016

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

May 11, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 28, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16296

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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