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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-30

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DOAC in Chinese Patients With Atrial Fibrillation

NCT05378035

Atrial Fibrillation Stroke Stroke, Acute +4 more

RECRUITING

Real-world Study on Edoxaban Treatment for Patients With Non-valvular Atrial Fibrillation in China

NCT04747496

Non-valvular Atrial Fibrillation

COMPLETED

Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation

NCT06108414

Atrial Fibrillation Anticoagulant Adverse Reaction Stroke +1 more

RECRUITING PHASE4

Real-world Research : Assessment of Effect of Combination of Drugs in the Treatment of Heart Failure

NCT06158711

Heart Failure

NOT_YET_RECRUITING

Effectiveness of Oral Anticoagulants in Elderly Patients With Non-Valvular Atrial Fibrillation and Heart Failure

NCT03508271

Atrial Fibrillation Heart Failure

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an open label study. Male or female patients with non-valvular atrial fibrillation (NVAF) with age ≥20 years, and meeting the indications of edoxaban are potentially eligible for the study. Patients receive Edoxaban 15mg、30mg or 60mg according to the criteria as following:

1. Patients with severe renal insufficiency (15ml/min ≤ CrCl \<30ml/min), 15mg quaque die (QD)
2. Patients with normal or mild renal insufficiency (CrCl ≥50ml/min), 60mg QD
3. Patients with moderate renal insufficiency (30ml/min ≤ CrCl \<50ml/min), weight ≤60kg or combined use of P-gp inhibitors (such as dronedarone，ketoconazole, erythromycin, etc), 30mg QD.

Patients will receive clinical evaluation at screening period, 4 weeks、8 weeks and 12 weeks after administration with Edoxaban. The following clinical evaluation items were included: body weight, vital signs (blood pressure and heart rate), CHADS2-VAS score, concomitant medication, ECG and echocardiogram, laboratory examination, safety evaluation (thromboembolic events, bleeding events, death) during treatment.

Additional blood samples are collected for pharmacokinetic evaluation at screening period, pre-dose, 2±1h and 6±1h after administration at 4-, 8-, and 12-week visit, and for pharmacodynamic evaluation (FXa) at screening period, pre-dose after administration at 4-, 8-, 12-week visit.

The population pharmacokinetics of Edoxaban in Chinese patients with non-valvular atrial fibrillation will be determined after 12weeks clinical observation.

The ENGAGE PopPK model suitable in Chinese Patients with Non-Valvular Atrial Fibrillation will be established.

Safety outcomes (thromboembolic events, bleeding events, death) will be evaluated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Valvular Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Edoxaban treatment

Group Type EXPERIMENTAL

Edoxaban

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Edoxaban

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No