Status:
RECRUITING
Population Pharmacokinetics of Edoxaban in Chinese Patients With Non-Valvular Atrial Fibrillation
Lead Sponsor:
China National Center for Cardiovascular Diseases
Collaborating Sponsors:
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Non-Valvular Atrial Fibrillation
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 patien...
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. Pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05320627
Start Date
March 30 2022
End Date
December 30 2024
Last Update
March 15 2024
Active Locations (1)
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1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037