Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region
XANTUS-EL
XANTUS-EL, Xarelto® on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Eastern EU, Middle East, Africa (EMEA) and Latin America (LATAM): A Non-interventional Study
2 other identifiers
observational
2,101
17 countries
17
Brief Summary
This international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2013
CompletedFirst Submitted
Initial submission to the registry
February 25, 2013
CompletedFirst Posted
Study publicly available on registry
February 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2016
CompletedJune 21, 2017
June 1, 2017
3 years
February 25, 2013
June 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adjudicated major bleeding events
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Safety variables will be summarized using descriptivestatistics based on adverse events collection
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
All cause mortality
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Outcomes (8)
Adjudicated symptomatic thromboembolic events
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Non-major bleeding, collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleedings
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Treatment satisfaction
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Adverse events rates in the different AF risk factor categories
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Persistence with rivaroxaban treatment
after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- +3 more secondary outcomes
Study Arms (1)
Group 1
Interventions
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.
Eligibility Criteria
Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or noncentral nervous system systemic embolism.
You may qualify if:
- 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 systemic embolism, and who consent to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (17)
Unknown Facility
Many Locations, Argentina
Unknown Facility
Many Locations, Azerbaijan
Unknown Facility
Many Locations, Bahrain
Unknown Facility
Many Locations, Chile
Unknown Facility
Many Locations, Colombia
Unknown Facility
Many Locations, Egypt
Unknown Facility
Many Locations, Georgia
Unknown Facility
ManyLocations, Jordan
Unknown Facility
Many Locations, Kazakhstan
Unknown Facility
Many Locations, Kenya
Unknown Facility
ManyLocations, Lebanon
Unknown Facility
Many Locations, Mexico
Unknown Facility
Many Locations, Russia
Unknown Facility
ManyLocations, Saudi Arabia
Unknown Facility
Many Locations, United Arab Emirates
Unknown Facility
Many Locations, Uruguay
Unknown Facility
Many Locations, Venezuela
Related Publications (2)
Kirchhof P, Haas S, Amarenco P, Turpie AGG, Bach M, Lambelet M, Hess S, Camm AJ. Causes of death in patients with atrial fibrillation anticoagulated with rivaroxaban: a pooled analysis of XANTUS. Europace. 2024 Jul 2;26(7):euae183. doi: 10.1093/europace/euae183.
PMID: 38941511DERIVEDKirchhof 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.
PMID: 29976287DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2013
First Posted
February 27, 2013
Study Start
January 14, 2013
Primary Completion
January 16, 2016
Study Completion
June 20, 2016
Last Updated
June 21, 2017
Record last verified: 2017-06