Coronary Artery Aneurysm

3

Review clinical trials related to Coronary Artery Aneurysm. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease

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.

Participants needed: 10
Trial details
Phase: Phase 4Age: 1-18Biological sex: AllType: InterventionalSponsor: Children's Hospital of Fudan UniversityUpdated: Sep 8, 2025Locations: 1
Eligibility criteria

Giant coronary artery aneurysm(s) in any coronary artery after acute stage of Ka... [+3]

Active bleeding or bleeding risk contraindicating anticoagulant therapy [+11]

Status: Recruiting

Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease

Based on population pharmacokinetic model-based simulation, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after acute Kawasaki disease was proposed. This exploratory trial aims to evaluate the feasibility, safety and effectiveness of rivaroxaban compared to warfarin for thromboprophylaxis in children aged over 2 years with giant coronary artery aneurysms after Kawasaki disease

Participants needed: 100
Trial details
Phase: Phase 4Age: 2-18Biological sex: AllType: InterventionalSponsor: Children's Hospital of Fudan UniversityUpdated: Jul 2, 2025Locations: 1
Eligibility criteria

Giant coronary artery aneurysm(s) in any coronary artery after acute stage of Ka... [+3]

Active bleeding or bleeding risk contraindicating anticoagulant therapy [+11]

Status: Recruiting

Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

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

Participants needed: 60
Trial details
Age: 2-18Biological sex: AllType: ObservationalSponsor: Children's Hospital of Fudan UniversityUpdated: May 29, 2025Locations: 1
Eligibility criteria

Giant coronary artery aneurysm(s) in any coronary artery after acute stage of Ka... [+2]

Active bleeding or bleeding risk contraindicating anticoagulant therapy [+2]