Evaluating Edoxaban in Chinese Patients with Atrial Fibrillation

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

This study is testing how well the blood thinner Edoxaban works in Chinese patients with atrial fibrillation to create a personalized dosing plan based on their kidney function.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (other gov)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05320627 on ClinicalTrials.gov

What this trial studies

This study assesses the population pharmacokinetics of Edoxaban in Chinese patients diagnosed with non-valvular atrial fibrillation (NVAF). It aims to develop a predictive dosing model tailored to the characteristics of this population, ensuring individualized treatment plans. Participants will receive Edoxaban at varying doses based on their renal function and will undergo clinical evaluations over a 12-week period to monitor efficacy and safety. Blood samples will also be collected for pharmacokinetic and pharmacodynamic assessments.

Who should consider this trial

Good fit: Ideal candidates include male or female patients aged 20 years or older with non-valvular atrial fibrillation requiring anticoagulant therapy.

Not a fit: Patients with valvular atrial fibrillation, severe renal insufficiency (CrCl < 15 ml/min), or contraindications to Edoxaban will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and safer dosing of Edoxaban for Chinese patients with atrial fibrillation.

How similar studies have performed: Other studies have shown success in pharmacokinetic modeling for anticoagulants, but this specific approach in the Chinese population is novel.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with the Valve replacement
2. Patients with valvular atrial fibrillation
3. Mild and severe anemia patients
4. CrCl\<15ml/min
5. Patients on dialysis, risk of bleeding, taking antiplatelet drugs, or taking other anticoagulants
6. Contraindicated to Edoxaban.
7. Life expectancy \< 6 months.
8. Hypertension defined as systolic and/or diastolic blood pressure \> 95th age percentile or poorly controlled hypertension
9. 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.
10. 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
11. Urine pregnancy test positive if female
12. Inability to cooperate with the study procedures
13. Participation in a study with an investigational drug or medical device within 30 days prior to screening
14. 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

Where this trial is running

Beijing, Beijing

• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Lu Hua, 1 — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Lei Tian

Conditions: Non-Valvular Atrial Fibrillation, Edoxaban, Population Pharmacokinetics