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

• Status: Not yet recruiting
• Trial end date: 2024-12-17
• Target enrollment: 0
• Participant gender: All

Summary

Based on the population pharmacokinetic data of Chinese patients with atrial fibrillation, the study will evaluate the suitability of the ENGAGE PopPK 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China National Center for Cardiovascular Diseases
• Collaborator: Chinese Academy of Medical Sciences, Fuwai Hospital
• Treatments: Edoxaban

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 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 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