Risk of major bleeding and associated health care resource utilization in non-valvular atrial fibrillation patients who initiated NOACs vs VKAs in the Hungarian population. A stratification on the propensity score method study.

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Study drug and medical condition

• Name of medicine:
  ELIQUIS

  XARELTO

  PRADAXA
• Name of medicine, other:
  Syncumar, Warfarin
• Study drug International non-proprietary name (INN) or common name:
  APIXABAN

  DABIGATRAN ETEXILATE

  RIVAROXABAN

  ACENOCOUMAROL

  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:
  10000

Study design details

• Main study objective:
  The primary objective of the study is to give a descriptive analysis of the utilization of NOACs (apixaban, dabigatran, rivaroxaban) and VKAs (warfarin, acenocoumarol) in patients with NVAF in daily clinical practice on a large administrative database. The secondary objective of the study is to compare major bleeding rates and associated health care resource utilization between each NOAC and VKA.
• Outcomes:
  Primary outcome measure will be: 1. safety outcome: major bleeding (intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal, bleeding that was fatal), Secondary outcome measure will be: 1. effectiveness outcome: ischemic/unspecified stroke, hemorrhagic stroke, or systemic embolism (SE), 2. safety outcomes: myocardial infarction (MI), transfusion (CABG bleeding issue), (as individual endpoints).
• Data analysis plan:
  All study variables, including baseline and outcome measures, will be analyzed descriptively and stratified by cohort. Crude incidence will be calculated as the number of events divided by person time. Pearson’s chi-square tests will be used to evaluate significant differences for dichotomous variables, Student’s t-tests will be used for continuous variables.