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

• ClinicalTrials.gov Identifier: NCT01606995
• Recruitment Status: Completed
• First Posted: May 28, 2012
• Last Update Posted: January 23, 2017
• Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Bayer

Tracking Information

• First Submitted Date: May 24, 2012
• First Posted Date: May 28, 2012
• Last Update Posted Date: January 23, 2017
• Study Start Date: June 2012
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 25, 2012)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 25, 2012)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Atrial Fibrillation

Intervention

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

Study Groups/Cohorts

Group 1

Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 22, 2016): 6784
• Original Estimated Enrollment (submitted: May 25, 2012): 6000
• Actual Study Completion Date: March 2015
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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
• Removed Location Countries: Greece, Italy, Spain

Administrative Information

• NCT Number: NCT01606995
• Other Study ID Numbers: 15914; XA1101 ( Other Identifier: Company internal )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bayer
• Study Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: January 2017