Clinical trial NCT02485873: Real-Life Evidence on Stroke Prevention in SPAF
Official title: REal-LIfe Evidence on Stroke Prevention in Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation (Prevention of Stroke)
Keywords: Non-valvular atrial fibrillation (NVAF)
Pevention
Stroke
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen, LP
First posted: 2015-06-30
Enrollment: 8607
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-valvular atrial fibrillation (NVAF)

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


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Within 1 year after treatment start
Secondary outcomes:
measure: Time to first occurrence of IS
timeFrame: Within 1 year after treatment start
measure: Time to first occurrence of TIA
timeFrame: Within 1 year after treatment start
measure: Time to first occurrence of IH
timeFrame: Within 1 year after treatment start
measure: Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage
timeFrame: Within 1 year after treatment start
measure: Time to first occurrence of MI
timeFrame: Within 1 year after treatment start
measure: Incidence density in study population of IS
timeFrame: Within 1 year after treatment start
measure: Incidence density in study population of TIA
timeFrame: Within 1 year after treatment start
measure: Incidence density in study population of IH
timeFrame: Within 1 year after treatment start
measure: Incidence density in study population of Other non-traumatic intracranial hemorrhage including subdural hemorrhage
timeFrame: Within 1 year after treatment start
measure: Incidence density in study population of MI
timeFrame: Within 1 year after treatment start
measure: Incidence density in study population of any of the following: IS, TIA, IH, Other non-traumatic intracranial hemorrhage including subdural hemorrhage, MI
timeFrame: Within 1 year after treatment start
Other outcomes:
Locations:
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: