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

Study acronym: RIVA-KG
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Trial status: Not Yet Recruiting to Recruitingv5 Show 7 more changesShow less
    • Primary endpoint revised
    • Start date changed from estimate of Jul 1, 2025 to Jun 1, 2025
    • Eligibility criteria shortened, about 33 words
    • Secondary endpoints: 7 to 15
    • Study description expanded, about 37 words
    • Site details revised
    • Study title expanded, about 4 words
  3. Start date: Dec 1, 2024 to Jul 1, 2025v4
  4. Primary completion date: Sep 1, 2025 to Jun 1, 2027
    • Start date: Mar 1, 2024 to Dec 1, 2024
    • Study completion date: Mar 1, 2026 to Sep 1, 2027
    v3
  5. Phase: Phase 3 to Phase 4v2 Show 11 more changesShow less
    • Enrollment target: 332 to 100
    • Primary completion date: Jan 1, 2025 to Sep 1, 2025
    • Start date: Mar 1, 2023 to Mar 1, 2024
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Study completion date: Jun 1, 2025 to Mar 1, 2026
    • Interventions: Aspirin or Clopidogrel (Drug), Rivaroxaban Oral Tablet or Suspension [Xarelto] (Drug), Warfarin (Drug) to Aspirin or Clopidogrel (Drug), Rivaroxaban Oral Tablet [Xarelto] (Drug), Warfarin (Drug)
    • Eligibility criteria shortened, about 75 words
    • Secondary endpoints: 9 to 7
    • Study description expanded, about 99 words
    • Study title shortened, about 3 words
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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
Trial Details
NCT Number NCT05643651
Lead Sponsor Children's Hospital of Fudan University
Conditions
(from sponsor)		 Kawasaki Disease, Coronary Artery Aneurysm
Related terms Coronary Aneurysm, Mucocutaneous Lymph Node Syndrome
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov