Clinical trial NCT01606995: Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation
Official title: Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Stroke
Embolism
Atrial fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2012-05-28
Enrollment: 6784
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Adjudicated major bleeding events
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy
Secondary outcomes:
measure: All cause mortality
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy
measure: Adjudicated symptomatic thromboembolic events
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy
measure: Persistence with rivaroxaban treatment: Reasons for any switch from or interruption of rivaroxaban treatment
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy
Other outcomes:
Locations:
city: Multiple Locations
country: Austria
city: Multiple Locations
country: Belgium
city: Multiple Locations
country: Canada
city: Multiple Locations
country: Czechia
city: Multiple Locations
country: Denmark
city: Multiple Locations
country: France
city: Multiple Locations
country: Germany
city: Multiple Locations
country: Hungary
city: Multiple Locations
country: Ireland
city: Multiple Locations
country: Israel
city: Multiple Locations
country: Moldova, Republic of
city: Multiple Locations
country: Netherlands
city: Multiple Locations
country: Norway
city: Multiple Locations
country: Poland
city: Multiple Locations
country: Portugal
city: Multiple Locations
country: Russian Federation
city: Multiple Locations
country: Slovakia
city: Multiple Locations
country: Slovenia
city: Multiple Locations
country: Sweden
city: Multiple Locations
country: Ukraine
city: Multiple Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.