Clinical trial NCT06993636: Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
Official title: Population Pharmacokinetic/Pharmacodynamic Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years With Giant Coronary Artery Aneurysm After Kawasaki Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kawasaki Disease
Coronary Artery Aneurysm
Rivaroxaban
Anticoagulant Drugs
Pharmacokinetics and Pharmacodynamics
Keywords: Kawasaki disease
Coronary artery aneurysm
Population pharmacokinetic and pharmacodynamic
rivaroxaban
anticoagulant
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged ≥2 years with giant coronary artery aneurysms after Kawasaki disease treated with rivaroxaban at the Children's Hospital of Fudan University

Brief summary: Based on an established Kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after Kawasaki disease who received rivaroxaban treatment. Rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms will be measured and analyzed to support the population pharmacokinetic/pharmacodynamic analysis


Eligibility criteria: Inclusion Criteria:

1. Giant coronary artery aneurysm(s) in any coronary artery after acute stage of Kawasaki disease. Giant coronary artery aneurysm(s) should be confirmed by two-dimensional echocardiography and meet the diagnostic criteria of Z-score ≥10 or coronary artery internal diameter ≥8mm;
2. Anticoagulant with antiplatelet drug therapy for anti-thromboprophylaxis is recommended for the next 6 months;
3. Children aged 2 years to \<18 years

Exclusion Criteria:

1. Active bleeding or bleeding risk contraindicating anticoagulant therapy
2. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment
3. Patients participating in clinical trials of other drugs at the same time

Primary outcomes:
measure: Rivaroxaban plasma concentration
timeFrame: From baseline to 6 months after rivaroxaban initiation, with scheduled sampling at the first hospitalization
measure: Rivaroxaban-calibrated anti-activated Factor X (FXa) activity
timeFrame: From baseline to 6 months after rivaroxaban initiation, with anti-FXa activity measured at the same time points as plasma concentration
Secondary outcomes:
measure: Occurrence of new thrombosis in coronary arteries
timeFrame: From baseline to 6 months after rivaroxaban initiation
measure: Composite of Major bleeding or Clinically relevant non-major bleeding event
timeFrame: From baseline to 6 months after rivaroxaban initiation
Other outcomes:
measure: Genetic polymorphism
timeFrame: Day 1
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Fang Liu, MD
role: STUDY_DIRECTOR
References: