Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region (XANTUS-EL)

June 20, 2017 updated by: Bayer

XANTUS-EL, Xarelto® on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Eastern EU, Middle East, Africa (EMEA) and Latin America (LATAM): A Non-interventional Study

This international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2101

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 non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or noncentral nervous system 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 systemic embolism, and who consent to participate in the study.

Exclusion Criteria:

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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, whichever is later
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Safety variables will be summarized using descriptivestatistics based on adverse events collection
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
All cause mortality
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjudicated symptomatic thromboembolic events
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Non-major bleeding, collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleedings
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Treatment satisfaction
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Adverse events rates in the different AF risk factor categories
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Persistence with rivaroxaban treatment
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Reasons for switch of rivaroxaban treatment
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Reasons for interruption of rivaroxaban treatment
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Healthcare resource
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Number of healthcare professional visits and hospitalizations due to anticoagulation therapy
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

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

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)

January 14, 2013

Primary Completion (Actual)

January 16, 2016

Study Completion (Actual)

June 20, 2016

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

February 25, 2013

First Posted (Estimate)

February 27, 2013

Study Record Updates

Last Update Posted (Actual)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16691
  • XA1206 (Other Identifier: 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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