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

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

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

Conditions3

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