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

Exclusion Criteria

• •1. Major ASCVD events (clinically documented ASCVD)
• •* 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