Trial Condition(s):
Atrial Fibrillation
Xarelto for prevention of stroke in patients with atrial fibrillation in Latinamerica and EMEA region (XANTUS-EL)
Bayer Identifier:
16691
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion 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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Kazakhstan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Russia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Venezuela | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Mexico | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Uruguay | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kenya | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Egypt | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ManyLocations, Saudi Arabia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ManyLocations, Jordan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ManyLocations, Lebanon | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, United Arab Emirates | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Argentina | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Bahrain | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Azerbaijan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Georgia | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Adjudicated major bleeding eventsTimeframe: 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 collectionTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- All cause mortalityTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Outcome
- Adjudicated symptomatic thromboembolic eventsTimeframe: 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 bleedingsTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- Treatment satisfactionTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- Adverse events rates in the different AF risk factor categoriesTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- Persistence with rivaroxaban treatmentTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- Reasons for switch of rivaroxaban treatmentTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- Reasons for interruption of rivaroxaban treatmentTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- Healthcare resourceNumber of healthcare professional visits and hospitalizations due to anticoagulation therapyTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Additional Information
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