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Researchers fine-tune blood thinner dosing for chinese heart patients

NCT ID NCT05320627

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how the blood thinner edoxaban behaves in 150 Chinese adults with non-valvular atrial fibrillation (an irregular heartbeat). The goal was to see if current dosing models fit Chinese patients and to create a more personalized dosing plan to improve effectiveness and reduce side effects. Participants gave blood samples to measure drug levels and clotting activity.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

150 people

The number who actually took part.

Started

Mar 2022

Finished

Oct 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100037, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.