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.
Study Type
OBSERVATIONAL
Enrollment
2,101
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.
Unnamed facility
Many Locations, Argentina
Unnamed facility
Many Locations, Azerbaijan
Unnamed facility
Many Locations, Bahrain
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
Adjudicated symptomatic thromboembolic events
Time frame: 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
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Treatment satisfaction
Time frame: 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
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Persistence with rivaroxaban treatment
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Reasons for switch of rivaroxaban treatment
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
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Unnamed facility
Many Locations, Chile
Unnamed facility
Many Locations, Colombia
Unnamed facility
Many Locations, Egypt
Unnamed facility
Many Locations, Georgia
Unnamed facility
ManyLocations, Jordan
Unnamed facility
Many Locations, Kazakhstan
Unnamed facility
Many Locations, Kenya
...and 7 more locations
Reasons for interruption of rivaroxaban treatment
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Healthcare resource
Number of healthcare professional visits and hospitalizations due to anticoagulation therapy
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later