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Non-Valvular Atrial FibrillationPhase 4NCT05320627

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

A Phase 4 study testing Edoxaban in people with Non-Valvular Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Non-Valvular Atrial Fibrillation
What is being tested?
Edoxaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
30 Mar 2022to 30 Oct 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 28Show fewer
  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100037

Other trials in China

About this study

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.

Read the detailed description

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.

Being tested
Edoxaban
Keywords
Edoxaban, Population Pharmacokinetics, Non-Valvular Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EdoxabanDrug

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

Study groups in NCT05320627
Study groupRoleWhat they receive
Edoxaban treatmentExperimentalNot described
Receives: Drug: Edoxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at the 4th, 8th and 12th week

  2. 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.

    Measured: at the 4th, 8th and 12th week

Secondary outcomes (1)

  1. safety evaluation

    Patients enrolled will be back to center for visit at scheduled timepoint. Adverse even will be recorded. The investigator will determine whether the patient is suitable to go on with the study.

    Measured: at the 4th, 8th and 12th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start30 Mar 2022
  3. Primary completion30 Aug 2024
  4. Study completion30 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05320627
Sponsor's protocol ID
EPP-AF-102
Status last verified
Mar 2026
First submitted
2 Apr 2022
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41679707

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Edoxaban in people with Non-Valvular Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

population pharmacokinetic evaluation (time frame: at the 4th, 8th and 12th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05320627, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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