Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)

Study type

• Study topic:
  Human medicinal product

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

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AA03) warfarin

  (B01AF) Direct factor Xa inhibitors

  (B01AE07) dabigatran etexilate
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  The study cohort consists of patients from six hospital district areas having a diagnosis of AF. The included geographically defined hospital districts are Northern Ostrobotnia, Northern Savonia, Central Finland, Pirkanmaa, Southwest, and Helsinki and Uusimaa.; ; Inclusion Criteria; Patients fulfilling the following criteria are included in the study:; • patient has an International Classification of Diseases (ICD-10 version 10) diagnosis code I48 for AF during 1.1.2004-30.06.2018 in any of the used registries; ; Exclusion Criteria; • Patients with permanent residence in Finland less than 12 months prior to index date.; • Patients with age below 18 years at index date.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Atrial fibrillation patients
• Estimated number of subjects:
  180000

Study design details

• Main study objective:
  To investigate risk of stroke, systemic thromboembolism, bleeding events and myocardial infarction among AF patients in relation to different OAC treatments including warfarin treatment with the data of different TTR levels compared also with patients without any OAC treatment.
• Outcomes:
  Stroke, Other systemic thromboembolic events excluding stroke, Myocardial infarction, Bleeding events, Mortality (all-cause), Mortality (stroke), Mortality (myocardial infarction), Mortality (systemic thromboembolic events excluding stroke), Mortality (bleeding events), Anemia, renal impairment, use of blood products
• Data analysis plan:
  Stratified incidence rates with 95% CIs will be estimated for each endpoint within the strata of the time in therapeutic INR range (TTR) categories, and other covariates. The crude and adjusted hazard ratio (HR) estimates with 95% CIs and P-values will be estimated within the TTR categories and NOACs and patients without any anticoagulation using the conventional Cox’s proportional hazards model adjusting for other covariates