Researchers fine-tune blood thinner dosing for chinese heart patients
NCT ID NCT05320627
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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150 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Oct 2024
- Lead sponsor
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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
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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
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Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037, China
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Other studies related to the condition(s) this trial covers.
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