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

This study is currently recruiting participants.
Verified June 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01606995
First received: May 24, 2012
Last updated: June 11, 2013
Last verified: June 2013
History of Changes

May 24, 2012
June 11, 2013
June 2012
December 2014   (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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
  • Adjudicated symptomatic thromboembolic events [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6000
July 2015
December 2014   (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
Both
18 Years and older
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Moldova, Republic of,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Slovakia,   Slovenia,   Spain,   Sweden,   Ukraine,   United Kingdom
 
NCT01606995
15914, XA1101
No
Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP