Atrial Fibrillation
Conditions
Brief summary
This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Pfizer
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals greater than or equal to 20 years old as of the index date * At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records * Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-2016. The first warfarin or apixaban prescription date during the identification period will be designated as the index date
Exclusion criteria
* Patient's medical records indicating pregnancy during the follow-up period * Patient's medical records indicating taking warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 6-months prior to the index date * Had \> 1 OAC prescription in the patient's medical records on the index date Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major bleeding among oral anticoagulant (OAC) initiators | Maximum 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of stoke/SE (secondary event) among OAC initiators | Maximum 3 years | — |
| Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr | Maximum 3 years | CCr creatinine clearance (\< 50ml/min and \> 50ml/min) |
| Incidence of cardiovascular/all cause death among OAC initiators | Maximum 3 years | — |
| Incidence of myocardial infarction among OAC initiators | Maximum 3 years | — |
| Incidence of thromboembolic events | Maximum 3 years | — |
| Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate) | Maximum 3 years | CCr (\< 50ml/min and \> 50ml/min) |
| Incidence of myocardial infarction among OAC initiators stratified by CCr | Maximum 3 years | CCr (\< 50ml/min and \> 50ml/min) |
| Incidence of major adverse cardiac event among OAC initiators stratified by CCr | Maximum 3 years | CCr (\< 50ml/min and \> 50ml/min) |
| Distribution of clinical characteristics among OAC initiators | Maximum 3 years | Clinical characteristics will be summarized using descriptive statistics |
| Incidence of major adverse cardiac event among OAC initiators | Maximum 3 years | — |
Countries
Japan
Outcome results
None listed