Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

Pradaxa

Name of medicine, other

Warfarin

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

28000
Study design details

Main study objective

To assess the safety and effectiveness of dabigatran and warfarin in patients diagnosed with non-valvular atrial fibrillation in the DoD population.

Outcomes

stroke (hemorrhagic, ischemic), major bleeding, Ischemic stroke, Hemorrhagic stroke, Major Intracranial bleeding, Major Extracranial bleeding (Major GI bleeding (upper and lower), Major Urogenital bleeding, Major Other bleeding), Transient ischemic attack (TIA), Myocardial infarction (MI),Venous thromboembolism (VTE, deep vein thrombosis DVT or pulmonary embolism PE), Death (all cause)

Data analysis plan

Patients will be followed until OAC discontinuation/switch, disenrollment, death, or study end (whichever occurs first). Baseline characteristics for the study cohorts will be described and compared for the dabigatran (DE) and warfarin cohorts before and after propensity score matching (PSM). Inferential statistics will be used to analyze post-match differences between cohorts. For categorical variables, chi-square tests will be used, and for interval variables, t-tests or, if distribution is not normal, Wilcoxon rank sum test will be conducted. For the comparison of baseline characteristics before and after PSM, a conventional alpha of 0.05 and two-tailed level of significance will be used unless otherwise specified. To compare the occurrence of primary and secondary outcomes between DE and warfarin cohorts, time to event will be investigated using non-parametric Kaplan-Meier (KM) survival analyses. Cox proportional hazards models will be implemented if the PSM leaves imbalance.