Atrial Fibrillation (Prevention of Stroke)
Conditions
Keywords
Non-valvular atrial fibrillation (NVAF), Pevention, Stroke
Brief summary
To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF) in a real-life setting
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
As prescribed by treating physicians
As prescribed by treating physicians
Sponsors
Janssen, LP
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years on the day of the first prescription of the study drug (= index date) during study selection window * Diagnosis of NVAF on start date of study or anytime during 365 days before this date * Availability of follow-up at least 180 days after the date of the first prescription of study drug within selection window of study (exposure start date) * Evidence of patient activity in the database during 90 days before the date of the first prescription of target drug within selection window.
Exclusion criteria
* Patients with valvular AF * Prescriptions of Oral Anticoagulants (OACs): VKA, Dabigatran, Rivaroxaban before index date * Prescription of more than one OAC on the index date or switch to another OAC during the follow-up period * Prescriptions of \< 15mg rivaroxaban at index date or during the follow-up period for patients in rivaroxaban cohort
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first occurrence of any of the following: Ischemic stroke (IS), Transient ischemic attack (TIA), Intracerebral hemorrhage (IH), Other non-traumatic intracranial hemorrhage including subdural hemorrhage, Myocardial infarction (MI) | Within 1 year after treatment start | Composite cardiovascular endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first occurrence of TIA | Within 1 year after treatment start | Single cardiovascular event |
| Time to first occurrence of IH | Within 1 year after treatment start | Single cardiovascular event |
| Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage | Within 1 year after treatment start | Single cardiovascular event |
| Time to first occurrence of MI | Within 1 year after treatment start | Single cardiovascular event |
| Incidence density in study population of IS | Within 1 year after treatment start | — |
| Time to first occurrence of IS | Within 1 year after treatment start | Single cardiovascular event |
| Incidence density in study population of IH | Within 1 year after treatment start | — |
| Incidence density in study population of Other non-traumatic intracranial hemorrhage including subdural hemorrhage | Within 1 year after treatment start | — |
| Incidence density in study population of MI | Within 1 year after treatment start | — |
| Incidence density in study population of any of the following: IS, TIA, IH, Other non-traumatic intracranial hemorrhage including subdural hemorrhage, MI | Within 1 year after treatment start | — |
| Incidence density in study population of TIA | Within 1 year after treatment start | — |
Countries
Germany
Outcome results
None listed