NCT06722521 GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification
| NCT ID | NCT06722521 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Asan Medical Center |
| Condition | Primary Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 7,435 participants |
| Start Date | 2025-07-09 |
| Primary Completion | 2032-06-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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
Eligibility Criteria
Inclusion Criteria 1. Adults aged 19 years and older 2. Asymptomatic patients with significant coronary calcification (Agatston score ≥ 100) and no physiologically significant coronary artery disease (CAD) * The coronary CT scan used to establish the CAC score must be performed within 3 years prior to randomization. * The assessment of physiological significance must be performed within 6 months prior to randomization 3. Participants will be eligible for inclusion regardless of prior statin or anti-platelet agents use. Exclusion Criteria 1. Major ASCVD events (clinically documented ASCVD) If at least one of the following criteria is present via patient history, physical examination, or medical records at the time of screening, the patient is not eligible: * Acute coronary syndrome (MI or unstable angina) * Coronary revascularization (PCI, CABG) or other arterial revascularization * Ischemic stroke (Not TIA) * Symptomatic peripheral arterial disease (history of claudication with ABI \<0