RecruitingPhase 4NCT06722521

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

Comparison of Intensive Lipid-Lowering Therapy With a Statin-Ezetimibe Combination (Without Aspirin) vs. Statin Monotherapy (With Aspirin) In Asymptomatic Patient With Coronary Artery Calcification

Sponsor

Asan Medical Center

Enrollment

7,435 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

Vascular Calcification Primary Prevention

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

Min Age: 19 Years

Inclusion Criteria5

Adults aged 19 years and older
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
Participants will be eligible for inclusion regardless of prior statin or anti-platelet agents use.

Exclusion Criteria24

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
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
Patients with familial hypercholesterolemia.
Patients with low-density lipoproteins cholesterol (LDL-C) ≥ 190 mg/dL regardless taking a statin or not.
Continuation of PCSK9 inhibitor is required during the clinical trial
Patients with chronic kidney disease (<eGFR 30mL/min/1.73m2)
Advanced liver disease (Child-Pugh B or C)
Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 5 times upper limit of normal).
History of gastrointestinal bleeding, peptic ulcer, or intracranial hemorrhage within 6 months prior screening
Patients with a history of organ transplantation who are on immunosuppressive therapy
Concurrent use of other medications that may increase bleeding risk such NOAC and warfarin
A history of significant allergic reaction to aspirin or statin/ezetimibe
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.
Life expectancy < 1 years for any non-cardiac or cardiac causes.
Patient's pregnant or breast-feeding or child-bearing potential.
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.
Unwillingness or inability to comply with the procedures described in this protocol