Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

RIVAROXABAN
APIXABAN
DABIGATRAN
WARFARIN

Medical condition to be studied

Atrial fibrillation
Population studied

Short description of the study population

The study population will comprise all adult OAC naïve NVAF patients in Norway who filled a prescription for an OAC (rivaroxaban, apixaban, dabigatran, warfarin) in the study period, defined as from 1 January 2014 to 30 June 2018 (or later depending on availability of data).

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Atrial fibrillation patients

Estimated number of subjects

70000
Study design details

Main study objective

To assess the effectiveness and safety of NOACs vs. VKA in patients with non-valvular atrial fibrillation.

Outcomes

- Ischemic stroke- Intracranial hemorrhage, - Overall stroke- Systemic embolism- Myocardial infarction- All-cause mortality- Major bleeding- Demographic characteristics- Clinical characteristics- Drug utilization patterns

Data analysis plan

Descriptive statistics will be used to present the data where continuous variables will be summarized as mean, standard deviation, median, minimum and maximum. Categorical variables will be described by frequencies and related percentages. Summaries will be reported separately for the elderly +75 years (cohort 1 and 2) and patients with renal impairment (cohort 2). Annual frequency of different OAC treatment during the study period in addition to adherence to each NOACs (high, moderate, low, and poor) will be presented. Also a separate analysis will be done to characterize patients with NVAF who have not been treated with OAC.