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GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2025 to Jul 9, 2025
    v10
  2. Start date: Jun 1, 2025 to Jul 1, 2025
    • Study title shortened, about 1 word
    v9
  3. Secondary endpoints: details revised at 1 of 11 entriesv8
  4. Start date: May 1, 2025 to Jun 1, 2025
    • Primary completion date: May 31, 2032 to Jun 30, 2032
    • Study completion date: Dec 31, 2032 to Oct 31, 2032
    • Secondary endpoints: 10 to 11
    v7
  5. Start date: Apr 1, 2025 to May 1, 2025v6 Show 4 more changesShow less
    • Enrollment target: 6504 to 7435
    • Primary completion date: Mar 31, 2032 to May 31, 2032
    • Eligibility criteria expanded, about 20 words
    • Study description shortened, about 4 words
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Start date: Mar 1, 2025 to Apr 1, 2025v4
  3. Eligibility criteria shortened, about 53 words
    • Study title expanded, about 1 word
    v3
  4. Interventions: Intensive lipid-lowering therapy without aspirin (Drug), Moderate-intensity lipid-lowering therapy with aspirin (Drug) to Pitavastatin 2 mg with aspirin 100 mg, taken once daily. (Drug), Pitavastatin 4mg and ezetimibe 10mg, taken once daily (Drug)
    • Eligibility criteria expanded, about 31 words
    • Study description expanded, about 3 words
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification
Trial Details
NCT Number NCT06722521
Lead Sponsor Asan Medical Center
Conditions
(from sponsor)		 Primary Prevention, Vascular Calcification
Related terms Cardiovascular Diseases, Vascular Calcification
Enrollment 7,435 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov