GUIDE-CAC: Intensive Lipid-Lowering Without Aspirin vs. Standard Therapy With Aspirin in High Coronary Calcification.

Launched by ASAN MEDICAL CENTER · Dec 4, 2024

Keywords

ClinConnect Summary

The GUIDE-CAC clinical trial is studying how effective and safe a combination treatment of a statin and ezetimibe (a type of cholesterol-lowering medication) is compared to taking a statin alone with aspirin. This trial focuses on people who have significant coronary artery calcification (a buildup of calcium in the arteries) but do not have any symptoms of heart disease. Researchers want to see if the intensive treatment without aspirin can help reduce risks for these patients.

To be eligible for this trial, participants must be at least 19 years old and have a specific score indicating coronary calcification (an Agatston score of 100 or more) without any significant heart disease. People with a history of serious heart events, certain types of kidney or liver disease, or those currently on certain medications may not be included. Those who join the study can expect regular check-ups and monitoring while trying out the new treatment approach. It’s important to note that the trial is not yet recruiting participants, but it aims to provide valuable insights into managing heart health for those at risk.

Gender

ALL

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 \<0.90, 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