Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

NCT06993636 | Recruiting

• 1 other identifier: RIVA-KD-PopPK
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Kawasaki Disease; Coronary Artery Aneurysm; Rivaroxaban; Anticoagulant Drugs; Pharmacokinetics and Pharmacodynamics

Keywords

Kawasaki disease; Coronary artery aneurysm; Population pharmacokinetic and pharmacodynamic; rivaroxaban; anticoagulant

Outcome Measures

Primary Outcomes (2)

• Rivaroxaban plasma concentration

  Opportunistic blood sampling will be performed at multiple predefined time points based on the principle of sparse sampling. It includes: 1. Day 1, 20 minutes -1 h after the first dose; 2. Day 1, 7±1 h after the first dose; 3. After at least three continuous doses (≥ Day 4): before the scheduled dose at that day, which is defined as the trough concentration; 4. After at least three continuous doses (≥ Day 4): 3±1 h the scheduled dose at that day, which is defined as the peak concentration. And peak and trough concentrations will be re-measured after each dose adjustment

  From baseline to 6 months after rivaroxaban initiation, with scheduled sampling at the first hospitalization

• Rivaroxaban-calibrated anti-activated Factor X (FXa) activity

  Opportunistic blood sampling will be performed at multiple predefined time points based on the principle of sparse sampling. It includes: 1. Day 1, 20 minutes -1 h after the first dose; 2. Day 1, 7±1 h after the first dose; 3. After at least three continuous doses (≥ Day 4): before the scheduled dose at that day, which is defined as the trough concentration; 4. After at least three continuous doses (≥ Day 4): 3±1 h the scheduled dose at that day, which is defined as the peak concentration. And peak and trough concentrations will be re-measured after each dose adjustment

  From baseline to 6 months after rivaroxaban initiation, with anti-FXa activity measured at the same time points as plasma concentration

Secondary Outcomes (2)

• Occurrence of new thrombosis in coronary arteries

  From baseline to 6 months after rivaroxaban initiation

• Composite of Major bleeding or Clinically relevant non-major bleeding event

  From baseline to 6 months after rivaroxaban initiation

Other Outcomes (1)

• Genetic polymorphism

  Day 1

Study Arms (1)

Rivaroxaban

Rivaroxaban as anticoagulant will be administered with antiplatelet drug for long-term antithrombotic treatment, following a model-based optimized dosing regimen. Rivaroxaban plasma concentration and rivaroxaban-calibrated Anti-FXa activity are measured for clinical monitoring

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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;
• Anticoagulant with antiplatelet drug therapy for anti-thromboprophylaxis is recommended for the next 6 months;
• Children aged 2 years to \<18 years

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome; Coronary Aneurysm

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Aneurysm

Study Officials

• Fang Liu, MD

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Central Study Contacts

Fang Liu, MD

CONTACT

18017590880; liufang@fudan.edu.cn

Guangan Dai, MD

CONTACT

13580762996; gadai24@m.fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 29, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)