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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
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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

Drug Information available for: Rivaroxaban

Groups and Cohorts
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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
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Primary Outcome Measures :
  1. Adjudicated major bleeding events [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy ]
  2. 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 :
  1. All cause mortality [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy ]
  2. Adjudicated symptomatic thromboembolic events [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy ]
  3. 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
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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
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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
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Additional Information:

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

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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