Rivaroxaban in Chinese Children With Giant Coronary Artery Aneurysm After Kawasaki Disease: a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Based on a population pharmacokinetic model-based dose optimization study, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after Kawasaki disease was proposed. This single-center, single-arm, pilot study aims to evaluate the feasibility of the 15 mg-equivalent dosing regimen within a limited sample size. Patients will be followed for more than 6 months. Clinical outcomes, including coronary artery thrombosis, major adverse cardiovascular events, and bleeding events, will be recorded. Rivaroxaban levels will be measured to assess the robustness of the model-informed dose optimization.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:

• 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;

• Participant should be able to tolerate oral feeding, nasogastric or gastric feeding;

• Children aged 1 Month to\<18 years, bodyweight ≥ 2600g.

Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Fang Liu, MD
liufang@fudan.edu.cn
18017590880
Backup
Guangan Dai, MD
gadai24@m.fudan.edu.cn
13580762996
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Rivaroxaban
Rivaroxaban as anticoagulant will be administered for children with giant coronary artery aneurysm after Kawasaki disease. The initial dosing regimen of rivaroxaban is a 15 mg-equivalent, age and bodyweight-adjusted dosing regimen, which was proposed by the model-informed dose optimization study.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Fudan University

This content was sourced from clinicaltrials.gov