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Clinical Trials in South Korea / NCT06722521
Recruiting Phase 4

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

NCT06722521 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 4
Started
2025-07-09
Last updated
2025-08-07

Condition(s) studied

Primary PreventionVascular Calcification

Investigational drug(s) / intervention(s)

Pitavastatin 4mg and ezetimibe 10mg, taken once dailyPitavastatin 2 mg with aspirin 100 mg, taken once daily.

Pitavastatin 4mg and ezetimibe 10mg, taken once daily: Intensive lipid-lowering therapy without aspirin

Pitavastatin 2 mg with aspirin 100 mg, taken once daily.: Moderate-intensity lipid-lowering therapy with aspirin

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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 \<0.90, or previous revascularization or amputation 2. Patients with physiologically significant CAD * Moderate to severe CAD (diameter stenosis \>50%) on CCTA with positive strest test (thallium, treadmil, stress echocardiography) * Moderate to severe CAD (diameter stenosis \>50%) on CAG with positive fractional flow reserve (FFR) \< 0.8 3. Patients with familial hypercholesterolemia. 4. Patients with low-density lipoproteins cholesterol (LDL-C) ≥ 190 mg/dL regardless taking a statin or not. 5. Continuation of PCSK9 inhibitor is required during the clinical trial 6. Patients with chronic kidney disease (\<eGFR 30mL/min/1.73m2) 7. Advanced liver disease (Child-Pugh B or C) 8. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 5 times upper limit of normal). 9. History of gastrointestinal bleeding, peptic ulcer, or intracranial hemorrhage within 6 months prior screening 10. Patients with a history of organ transplantation who are on immunosuppressive therapy 11. Concurrent use of other medications that may increase bleeding risk such NOAC and warfarin 12. A history of significant allergic reaction to aspirin or statin/ezetimibe 13. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer. 14. Life expectancy \< 1 years for any non-cardiac or cardiac causes. 15. Patient's pregnant or breast-feeding or child-bearing potential. 16. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study. 17. Unwillingness or inability to comply with the procedures described in this protocol

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Asan Medical Center Seoul South Korea Recruiting

More Asan Medical Center trials in South Korea

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06722521 on ClinicalTrials.gov ↗ ← All trials in South Korea