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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:
Information provided by (Responsible Party):

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

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
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

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 :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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


  Show 21 Study Locations
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01606995     History of Changes
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:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants