Real-Life Evidence on Stroke Prevention in SPAF

Study Overview
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Brief Summary
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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

Official Title
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REal-LIfe Evidence on Stroke Prevention in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation (Prevention of Stroke)

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Vitamin K antagonists


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rivaroxaban<br>Non-valvular Atrial Fibrillation (NVAF) patients who were initiated on rivaroxaban for stroke prevention | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* As prescribed by treating physicians<br>|
| Vitamin K antagonists (VKA)<br>NVAF patients who were initiated on VKA (predominately phenprocoumon in Germany) for stroke prevention | Drug: Vitamin K antagonists<br>* As prescribed by treating physicians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Composite cardiovascular endpoint | Within 1 year after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first occurrence of IS | Single cardiovascular event | Within 1 year after treatment start | 
| Time to first occurrence of TIA | Single cardiovascular event | Within 1 year after treatment start | 
| Time to first occurrence of IH | Single cardiovascular event | Within 1 year after treatment start | 
| Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage | Single cardiovascular event | Within 1 year after treatment start | 
| Time to first occurrence of MI | Single cardiovascular event | Within 1 year after treatment start | 
| Incidence density in study population of IS |  | Within 1 year after treatment start | 
| Incidence density in study population of TIA |  | Within 1 year after treatment start | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-valvular atrial fibrillation (NVAF), Pevention, Stroke