Study type

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Observational cohort Study
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

A retrospective observational cohort study of NVAF patients treated for the prevention of stroke with OACs after NVAF diagnosis using large insurance claims data.
Study drug and medical condition

Name of medicine

ELIQUIS

Medical condition to be studied

Atrial fibrillation
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

30000
Study design details

Main study objective

To Compare the incidence of major bleeding events among NVAF patients newly initiated with apixaban versus each other OACs for 1 year after initiation of each OAC.

Outcomes

Incidence of major bleeding will be compared between apixaban and warfarin. Incidence of and time to any bleeding among NVAF patients treated with apixaban, which are compared with other NOACs or warfarin.A rate of discontinuation and time to discontinuation of each OAC.Health-care resource utilization.

Data analysis plan

Baseline patient demographics information and healthcare resource utilization will be compared among the apixaban, rivaroxaban, dabigatran and warfarin cohorts by using chi-square test(categorical variables) and ANOVA with a post-hoc test (numerous variables). COX proportional hazard regression analysis will be used to compare the incidence of post treatment major bleeding among four OAC groups. Discontinuation of or switching from an index OAC will be compared among four OACs by using COX proportional hazard regression analysis.