Clinical trial NCT01800006: Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Observation
Stroke
Embolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2013-02-27
Enrollment: 2101
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 non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or noncentral nervous system systemic embolism.

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.


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 systemic embolism, and who consent to participate in the study.

Exclusion Criteria:

Primary outcomes:
measure: Adjudicated major bleeding events
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Safety variables will be summarized using descriptivestatistics based on adverse events collection
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: All cause mortality
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary outcomes:
measure: Adjudicated symptomatic thromboembolic events
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: 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
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Treatment satisfaction
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Adverse events rates in the different AF risk factor categories
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Persistence with rivaroxaban treatment
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Reasons for switch of rivaroxaban treatment
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Reasons for interruption of rivaroxaban treatment
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Healthcare resource
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Other outcomes:
Locations:
city: Many Locations
country: Argentina
city: Many Locations
country: Azerbaijan
city: Many Locations
country: Bahrain
city: Many Locations
country: Chile
city: Many Locations
country: Colombia
city: Many Locations
country: Egypt
city: Many Locations
country: Georgia
city: ManyLocations
country: Jordan
city: Many Locations
country: Kazakhstan
city: Many Locations
country: Kenya
city: ManyLocations
country: Lebanon
city: Many Locations
country: Mexico
city: Many Locations
country: Russian Federation
city: ManyLocations
country: Saudi Arabia
city: Many Locations
country: United Arab Emirates
city: Many Locations
country: Uruguay
city: Many Locations
country: Venezuela
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.