AF In Real practice on Management of oral Anticoagulation (AFIRMA 4.0)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  To perform a study of NVAF patients based on real-world data through the reuse of electronic health records (EHRs)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  DABIGATRAN ETEXILATE

  RIVAROXABAN

  EDOXABAN

  WARFARIN

  ACENOCOUMAROL
• Medical condition to be studied:
  Atrial fibrillation
• Additional medical condition(s):
  STROKESYSTEMIC EMBOLISMMAJOR AND MINOR BLEEDING EVENTS

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:
  60000

Study design details

• Main study objective:
  The overall objective is to perform a study of NVAF patients based on real-world data through the reuse of electronic health records (EHRs). This approach avoids missing valuable information, and reduces biases normally present in this type of studies.
• Outcomes:
  To describe the demographic and clinical characteristics, including comorbidities, for OAC patients who were prescribed apixaban, dabigatran, rivaroxaban, edoxaban, acenocumarol or warfarin, • To describe treatment pathways, and report annual incidence rates of stroke/SE, major and minor bleedings for patients receiving OACs • To compare the rates of stroke/SE, major and minor bleedings and evaluated comparative rates across various subgroups among NVAF patients receiving OACs • To describe bleeding and stroke-related health care resource utilization in the study populations
• Data analysis plan:
  The methodology of this study is based on SAVANA, a data-driven system based on NLP and big data techniques, designed to analyse unstructured data contained in the electronic medical files. Eligible patients will be assigned to one of the OAC cohort (apixaban, dabigatran, rivaroxaban, edoxaban, warfarin, or acenocumarol). One-to-one propensity score matching (PSM) will be conducted between NOACs and acenocumarol and between the NOACs. As well as overall NOACs versus VKA (acenocumarol and warfarin). Patients will be matched 1:1 in each data set based on the propensity scores generated.