RecruitingPhase 4NCT05320627

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

Sponsor

China National Center for Cardiovascular Diseases

Enrollment

120 participants

Start Date

Mar 30, 2022

Study Type

INTERVENTIONAL

Conditions

Non Valvular Atrial Fibrillation

Summary

Based on the population pharmacokinetic data of Chinese patients with atrial fibrillation, the study will evaluate the suitability of the ENGAGE Population Pharmacokinetics model of edoxaban in patients with atrial fibrillation in China, and build a predictive dose model of edoxaban that meets the characteristics of Chinese people. It can provide perfect individualized dosing plan improves clinical efficacy and reduces adverse drug reactions.

Eligibility

Min Age: 20 Years

Inclusion Criteria5

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

Exclusion Criteria27

Patients with the Valve replacement
Patients with valvular atrial fibrillation
Mild and severe anemia patients
CrCl\<15ml/min
Patients on dialysis, risk of bleeding, taking antiplatelet drugs, or taking other anticoagulants
Contraindicated to Edoxaban.
Life expectancy \< 6 months.
Hypertension defined as systolic and/or diastolic blood pressure \> 95th age percentile or poorly controlled hypertension
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
Urine pregnancy test positive if female
Inability to cooperate with the study procedures
Participation in a study with an investigational drug or medical device within 30 days prior to screening
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