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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01606995
First Posted: May 28, 2012
Last Update Posted: January 23, 2017
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.
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
May 24, 2012
May 28, 2012
January 23, 2017
June 2012
March 2015   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01606995 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism
Atrial Fibrillation
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
Group 1
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6784
March 2015
March 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Hungary,   Ireland,   Israel,   Moldova, Republic of,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Slovakia,   Slovenia,   Sweden,   Ukraine,   United Kingdom
Greece,   Italy,   Spain
 
NCT01606995
15914
XA1101 ( Other Identifier: Company internal )
No
Not Provided
Not Provided
Bayer
Bayer
Janssen Research & Development, LLC
Study Director: Bayer Study Director Bayer
Bayer
January 2017
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