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
Overview
- Phase
- Not Applicable
- Intervention
- Rivaroxaban (Xarelto, BAY59-7939)
- Conditions
- Atrial Fibrillation
- Sponsor
- Bayer
- Enrollment
- 2101
- Primary Endpoint
- Adjudicated major bleeding events
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
- Not provided
Arms & Interventions
Group 1
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Outcomes
Primary Outcomes
Adjudicated major bleeding events
Time Frame: 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
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
All cause mortality
Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Outcomes
- Healthcare resource(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
- 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)
- Reasons for switch of rivaroxaban treatment(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
- Reasons for interruption of rivaroxaban treatment(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)