CompletedPhase 4

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

China150 participantsStarted 2022-03-30

Plain-language 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 Chinese people. It can provide perfect individualized dosing plan improves clinical efficacy and reduces adverse drug reactions.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

population pharmacokinetic evaluation

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

pharmacokinetic evaluation

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

Trial details

NCT IDNCT05320627

SponsorChina National Center for Cardiovascular Diseases

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-08-30

View on ClinicalTrials.gov More Non-Valvular Atrial Fibrillation trials