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

NCT05320627 | Completed Phase 4

• 1 other identifier: EPP-AF-102
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Valvular Atrial Fibrillation

Keywords

Edoxaban; Population Pharmacokinetics; Non-Valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• population pharmacokinetic evaluation

  Patients enrolled will be back to center for visit at scheduled timepoint. Blood sample for PopPK study was collected. Edoxaban concentrations in patient plasma will be determined, which will be analysed and compared with ENGAGE PopPK model.

  at the 4th, 8th and 12th week

• pharmacokinetic evaluation

  Patients enrolled will be back to center for visit at scheduled timepoint. Blood for pharmacodynamic sample will be collected for Anti-FXa activity determination.

  at the 4th, 8th and 12th week

Secondary Outcomes (1)

• safety evaluation

  at the 4th, 8th and 12th week

Study Arms (1)

Edoxaban treatment

EXPERIMENTAL

Drug: Edoxaban

Interventions

Edoxaban DRUG

Eligible patients will receive Edoxaban tablet once a day for 12 weeks

Edoxaban treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (1)

• Deng Y, Dai S, Zhu S, Jiang J, Chai L, Liu Z, Qian X, Chong L, Hu S, Gao Y, Chen H, Su S, Hua L, Tian L. Edoxaban Population Pharmacokinetics in Chinese Patients with Nonvalvular Atrial Fibrillation: Model-Informed Dose Adjustment. Thromb Haemost. 2026 Feb 12. doi: 10.1055/a-2802-3641. Online ahead of print.

  PMID: 41679707 DERIVED

MeSH Terms

Interventions

edoxaban

Study Officials

• Lu Hua, 1

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

• Lei Tian, 2

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 11, 2022
• Study Start: March 30, 2022
• Primary Completion: August 30, 2024
• Study Completion: October 30, 2024
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)