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

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ClinicalTrials.gov Identifier: NCT01606995

Recruitment Status : Completed

First Posted : May 28, 2012

Last Update Posted : January 23, 2017

Sponsor:

Collaborator:

Janssen Research & Development, LLC

Information provided by (Responsible Party):

Bayer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Atrial Fibrillation	Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study Design

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Study Type :	Observational
Actual Enrollment :	6784 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation
Study Start Date :	June 2012
Actual Primary Completion Date :	March 2015
Actual Study Completion Date :	March 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Rivaroxaban

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

Adjudicated major bleeding events [ Time Frame: 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 ]

Secondary Outcome Measures :

All cause mortality [ Time Frame: 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 ]
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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606995

Locations

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Austria

Many Locations, Austria
Belgium

Many Locations, Belgium
Canada

Many Locations, Canada
Czech Republic

Many Locations, Czech Republic
Denmark

Many Locations, Denmark
France

Many Locations, France
Germany

Many Locations, Germany
Hungary

Many Locations, Hungary
Ireland

Many Locations, Ireland
Israel

Many Locations, Israel
Moldova, Republic of

Many Locations, Moldova, Republic of
Netherlands

Many Locations, Netherlands
Norway

Many Locations, Norway
Poland

Many Locations, Poland
Portugal

Many Locations, Portugal
Russian Federation

Many Locations, Russian Federation
Slovakia

Many Locations, Slovakia
Slovenia

Many Locations, Slovenia
Sweden

Many Locations, Sweden
Ukraine

Many Locations, Ukraine
United Kingdom

Many Locations, United Kingdom

Sponsors and Collaborators

Bayer

Janssen Research & Development, LLC

Investigators

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Study Director:	Bayer Study Director	Bayer

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kirchhof P, Haas S, Amarenco P, Hess S, Lambelet M, van Eickels M, Turpie AGG, Camm AJ; XANTUS Investigators*. Impact of Modifiable Bleeding Risk Factors on Major Bleeding in Patients With Atrial Fibrillation Anticoagulated With Rivaroxaban. J Am Heart Assoc. 2020 Mar 3;9(5):e009530. doi: 10.1161/JAHA.118.009530. Epub 2020 Feb 21.

Amarenco P, Haas S, Hess S, Kirchhof P, Lambelet M, Bach M, Turpie AGG, Camm AJ. Outcomes associated with non-recommended dosing of rivaroxaban: results from the XANTUS study. Eur Heart J Cardiovasc Pharmacother. 2019 Apr 1;5(2):70-79. doi: 10.1093/ehjcvp/pvy041.

Kirchhof P, Radaideh G, Kim YH, Lanas F, Haas S, Amarenco P, Turpie AGG, Bach M, Lambelet M, Hess S, Camm AJ; Global XANTUS program Investigators. Global Prospective Safety Analysis of Rivaroxaban. J Am Coll Cardiol. 2018 Jul 10;72(2):141-153. doi: 10.1016/j.jacc.2018.04.058.

Camm AJ, Turpie AGG, Hess S, Amarenco P, Lambelet M, Haas S, van Eickels M, Kirchhof P; XANTUS Investigators. Outcomes after catheter ablation and cardioversion in patients with non-valvular atrial fibrillation: results from the prospective, observational XANTUS study. Europace. 2018 Jun 1;20(6):e87-e95. doi: 10.1093/europace/eux127.

Camm AJ, Amarenco P, Haas S, Hess S, Kirchhof P, Kuhls S, van Eickels M, Turpie AG; XANTUS Investigators. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J. 2016 Apr 7;37(14):1145-53. doi: 10.1093/eurheartj/ehv466. Epub 2015 Sep 1.

Camm AJ, Amarenco P, Haas S, Hess S, Kirchhof P, van Eickels M, Turpie AG. XANTUS: rationale and design of a noninterventional study of rivaroxaban for the prevention of stroke in patients with atrial fibrillation. Vasc Health Risk Manag. 2014 Jul 17;10:425-34. doi: 10.2147/VHRM.S63298. eCollection 2014.

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Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT01606995
Other Study ID Numbers:	15914 XA1101 ( Other Identifier: Company internal )
First Posted:	May 28, 2012 Key Record Dates
Last Update Posted:	January 23, 2017
Last Verified:	January 2017

Keywords provided by Bayer:


Stroke Embolism Atrial fibrillation

Additional relevant MeSH terms:

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Atrial Fibrillation Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases Pathologic Processes Rivaroxaban Factor Xa Inhibitors	Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants

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