Atrial Fibrillation
Conditions
Keywords
Stroke, Embolism, Atrial Fibrillation
Brief summary
This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
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.
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (Central Nervous System) systemic embolism, and who consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 descriptive statistics 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
| Measure | Time frame | Description |
|---|---|---|
| Healthcare resource | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | Number of healthcare professional visits and hospitalizations due to anticoagulation |
| 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 | — |
| Adjudicated symptomatic thromboembolic events | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | — |
| Reasons for switch of rivaroxaban treatment as per physician assessment during or at end of study | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | — |
| Reasons for interruption of rivaroxaban treatment as per physician assessment during or at end of study | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | — |
| Persistence with rivaroxaban treatment measured as percentage of patients on rivaroxaban treatment at 1 year after start of study treatment | 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 as per patient assessment of rivaroxaban treatment by the physician at the final visit | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | — |
Countries
Hong Kong, India, Indonesia, Malaysia, Pakistan, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
Outcome results
None listed