Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Observation, Stroke, 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.
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 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 descriptivestatistics 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 |
|---|---|---|
| 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 | — |
| Adjudicated symptomatic thromboembolic events | 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 | — |
| 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 therapy |
| Reasons for switch of rivaroxaban 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 | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | — |
Countries
Argentina, Azerbaijan, Bahrain, Chile, Colombia, Egypt, Georgia, Jordan, Kazakhstan, Kenya, Lebanon, Mexico, Russia, Saudi Arabia, United Arab Emirates, Uruguay, Venezuela
Outcome results
None listed