Actively Recruiting
Comparison of Intensive Lipid-Lowering Therapy With a Statin-Ezetimibe Combination Without Aspirin Versus Statin Monotherapy With Aspirin in Asymptomatic Patients With Coronary Artery Calcification
Led by Asan Medical Center · Updated on 2025-08-07
7435
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best way to prevent cardiovascular events in people who have significant coronary artery calcification but no symptoms. This study compares two approaches: intensive lipid-lowering therapy using a combination of pitavastatin and ezetimibe without aspirin, versus moderate-intensity statin therapy with aspirin. The goal is to determine if the combination without aspirin is as effective and safe as the statin with aspirin in these higher-risk yet asymptomatic patients. Participants are randomly assigned to one of two treatment groups. One group receives pitavastatin 4 mg combined with ezetimibe 10 mg daily without aspirin. The other group receives pitavastatin 2 mg with aspirin 100 mg daily, with the possibility of increasing the statin dose or switching aspirin to clopidogrel depending on clinical judgment and individual response. These treatments are given to patients with a coronary artery calcification score of 100 or higher who do not have significant coronary artery disease. During the study, researchers will monitor participants over 48 months to track major cardiovascular events such as heart attacks, strokes, urgent procedures, and deaths. They will also assess lipid profiles, bleeding events, and serious side effects that lead to stopping the study drug. Participants will undergo regular evaluations including clinical assessments and laboratory tests to monitor their health and treatment response throughout the trial period.
CONDITIONS
Brief Title
GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years and older
- Asymptomatic patients with significant coronary artery calcification (Agatston score 25100) and no physiologically significant coronary artery disease
- Coronary CT scan to determine calcification score performed within 3 years before randomization
- Assessment of physiological significance of coronary artery disease within 6 months before randomization
- Eligible regardless of prior statin or anti-platelet agent use
You will not qualify if you...
- History of major atherosclerotic cardiovascular disease events such as acute coronary syndrome, coronary revascularization, ischemic stroke (not transient ischemic attack), or symptomatic peripheral arterial disease
- Physiologically significant coronary artery disease defined by moderate to severe stenosis (>50%) confirmed by coronary CT angiography or coronary angiography with positive stress tests or fractional flow reserve <0.8
- Familial hypercholesterolemia
- LDL cholesterol 25190 mg/dL regardless of statin use
- Required continuation of PCSK9 inhibitor during trial
- Chronic kidney disease with eGFR <30 mL/min/1.73m2
- Advanced liver disease (Child-Pugh B or C)
- Hepatic disease, biliary obstruction, or significant liver enzyme elevation (ALT or AST >5 times the upper limit)
- History of gastrointestinal bleeding, peptic ulcer, or intracranial hemorrhage within 6 months before screening
- History of organ transplantation requiring immunosuppressive therapy
- Use of medications that increase bleeding risk such as NOAC or warfarin
- Significant allergy to aspirin or statin/ezetimibe
- Cancer diagnosis (except superficial skin cancers) within past 3 years or ongoing cancer treatment
- Life expectancy less than 1 year
- Pregnancy, breastfeeding, or childbearing potential
- Any clinically significant abnormality at screening that would prevent safe study completion
- Inability or unwillingness to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 months
Participants receive intensive lipid-lowering therapy with a statin-ezetimibe combination without aspirin or statin monotherapy with aspirin to reduce cardiovascular risk.
Regular visits as per study schedule
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
S
Seung-Whan Lee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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