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Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase changed: not specified → Phase 3v2 Show 5 more changesShow less
    • Recruitment opened
    • Trial arms changed: 0 → 4
    • Start date changed from estimate of Mar 30, 2026 to Jun 8, 2026
    • Interventions: Atorvastatin-acute KD with CAA (Drug) to atorvastatin of dose level 1 (Drug), atorvastatin of dose level 2 (Drug), atorvastatin of dose level 3 (Drug)
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to learn about the safety and effects of atorvastatin in treatment of Chinese Kawasaki disease (KD) children complicated with coronary artery abnormalities (CAA) in acute phase. The main questions it aims to answer are: Is atorvastatin safe in Chinese children of acute KD? Does atorvastatin contribute to control the acute inflammation in KD and improve the CAA?
Trial Details
NCT Number NCT07530640
Lead Sponsor Children's Hospital of Fudan University
Conditions
(from sponsor)		 Kawasaki Disease, Coronary Artery Abnormalities
Related terms Mucocutaneous Lymph Node Syndrome
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov