Plasma concentrations of direct oral anticoagulants in patients with atrial fibrillation.

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Drug adherence and pharmacokinetics

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  APIXABAN
• 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:
  200

Study design details

• Main study objective:
  To investigate the variation in DOAC serum levels in patients with expected optimal adherence and how adherence to DOACs influences this variation.
• Outcomes:
  To investigate the variation in DOAC serum levels in patients with expected optimal adherence and how adherence to DOACs influences this variation. Relationship between MMAS-8 scores and concentration dose ratios (CDRs) of DOACs just before ablation, effect of age, sex, renal function on CDRs just before ablation, relationship between MMAS-8 scores and CDRs 3 months after ablation, effect of age, sex, renal function on CDRs 3 months after ablation, relationship between MMAS-8 scores just before ablation and 3 months after ablation
• Data analysis plan:
  - relationship between MMAS-8 scores and concentration dose ratios (CDRs) of DOACs just before ablation - effect of age, sex, renal function on CDRs just before ablation - relationship between MMAS-8 scores and CDRs 3 months after ablation - effect of age, sex, renal function on CDRs 3 months after ablation - relationship between MMAS-8 scores just before ablation and 3 months after ablation