Population Pharmacokinetics of Edoxaban in Chinese Patients With Non-Valvular Atrial Fibrillation

Prior treatment

• Participation in a study with an investigational drug or medical device within 30 days prior to screening
• Additional exclusion criteria included, but were not limited to:
  • cerebral infarction or transient ischemic attack within the past 30 days
  • comorbid rheumatic valvular disease
  • comorbid infective endocarditis or atrial myxoma
  • evidence of thrombus in the left ventricle or atrium, or hereditary tendency for thrombus formation scheduled electrical or pharmacological defibrillation during the treatment period
  • acute myocardial infarction, or unstable angina
  • a diagnosis of active malignant tumor or cancer treatment within the past 5 years
  • previous treatment with Edoxaban

Other illness

• Patients on dialysis, risk of bleeding, taking antiplatelet drugs, or taking other anticoagulants

Lab values

• Hepatic disease which is associated either: with coagulopathy leading to a clinically relevant bleeding risk, or alanine transaminase (ALT) \> 5x upper level of normal (ULN), or total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total.
• Active bleeding or high risk for bleeding contraindicating anticoagulant therapy. For example：
  • a history of intracranial, intraocular, intraspinal, retroperitoneal, or traumatic intra-articular bleeding
  • gastrointestinal bleeding during the prior year
  • peptic ulcer within the previous 90 days
  • surgery or injury requiring hospitalization within the previous 30 days
  • hemoglobin \<9 g/dl or a platelet count \<50×109/L
  • active bleeding at registration
  • any procedure associated with bleeding planned to occur during the treatment period

Age

• Hypertension defined as systolic and/or diastolic blood pressure \> 95th age percentile or poorly controlled hypertension

Other

• Patients with the Valve replacement
• Patients with valvular atrial fibrillation
• Mild and severe anemia patients
• CrCl\<15ml/min
• Contraindicated to Edoxaban.
• Life expectancy \< 6 months.
• Urine pregnancy test positive if female
• Inability to cooperate with the study procedures

• Male or female NVAF patients, who need anticoagulant therapy at least 3 months
• Age ≥20 years,
• Creatinine clearance rate ≥ 15 ml/min
• Sign a written informed consent form (ICF) for participating in the study
• No simultaneous participation in any interventional study