Kawasaki DiseaseNCT06993636
Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
An observational study of Kawasaki Disease and Coronary Artery Aneurysm, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Kawasaki Disease, Coronary Artery Aneurysm, Rivaroxaban
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Fang Liu, MD., 18017590880, liufang@fudan.edu.cn
Fang Liu, MD
About this study
Official title: Population Pharmacokinetic/Pharmacodynamic Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years With Giant Coronary Artery Aneurysm After Kawasaki Disease
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
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome, Coronary Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
It is binary variable. Every echocardiography conducted during study period will be documented. Researcher will document whether new thrombosis occurs in coronary arteries, and record the number of involved coronary arteries.
Measured: From baseline to 6 months after rivaroxaban initiation
Composite of Major bleeding or Clinically relevant non-major bleeding event
It is a binary variable. Researcher will document major bleeding or clinically relevant non-major bleeding events. Major bleeding is defined as 1.Fatal bleeding; 2.Clinically overt bleeding associated with a decrease in Hemoglobin of ≥20 g/L in a 24-h period; 3.Critical site bleeding, such as retroperitoneal, pulmonary, pericardial, intracranial, or otherwise involves the central nervous system; 4.Bleeding that requires an intervention via an invasive procedure; 5.Overt bleeding for which a reversal agent is administered. Clinically relevant non-major bleeding event is defined as 1.Bleeding that results in a medical or procedural intervention not meeting major bleeding criteria, including a medication change (reducing, holding, or changing anticoagulation or addition of new medication) ; 2.Bleeding that results in hospitalization or increased level of care; 3.Overt bleeding for which a blood product is administered, and does not meet the criteria for major bleeding
Measured: From baseline to 6 months after rivaroxaban initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fang Liu, MD, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993636
- Sponsor's protocol ID
- RIVA-KD-PopPK
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No