Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation (XANTUS)

August 1, 2022 updated by: Bayer

Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation

This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6784

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

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism

Description

Inclusion Criteria:

  • Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS (Central Nervous System) systemic embolism, and who consent to participate in the study

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
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adjudicated major bleeding events
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy
after 1 year or until 30 days after end of rivaroxaban therapy
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy
after 1 year or until 30 days after end of rivaroxaban therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy
after 1 year or until 30 days after end of rivaroxaban therapy
Adjudicated symptomatic thromboembolic events
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy
after 1 year or until 30 days after end of rivaroxaban therapy
Persistence with rivaroxaban treatment: Reasons for any switch from or interruption of rivaroxaban treatment
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy
after 1 year or until 30 days after end of rivaroxaban therapy

Collaborators and Investigators

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

Sponsor

Bayer

Collaborators

Janssen Research & Development, 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

Helpful Links

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)

June 12, 2012

Primary Completion (ACTUAL)

March 6, 2015

Study Completion (ACTUAL)

March 31, 2015

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

May 25, 2012

First Posted (ESTIMATE)

May 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15914
  • XA1101 (OTHER: Company internal)

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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