Actively Recruiting
Comparison of High-Intensity Statin and Ezetimibe Combination Versus Standard Care in Asymptomatic Patients with Coronary Artery Calcification Evaluation of Safety and Efficacy for Primary Prevention of Cardiovascular Events
Led by Samsung Medical Center · Updated on 2025-01-14
6000
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining high-intensity statin therapy with ezetimibe compared to the current standard lipid-lowering treatment in asymptomatic patients who have significant coronary artery calcium buildup. This Phase 4 study focuses on primary prevention of cardiovascular events in people without symptoms but with coronary calcification, a marker linked to higher risk of heart disease. The study aims to address the limited evidence regarding aggressive lipid-lowering strategies using this combination in such patients. Participants will receive either the standard guideline-directed statin therapy, consisting of at least moderate intensity statins based on ASCVD risk, or an aggressive treatment combining high-intensity rosuvastatin (20 mg) with ezetimibe (10 mg). The treatments are compared to assess their impact on cardiovascular outcomes in patients who have an Agatston Score of 100 or higher, indicating significant coronary calcium. During the study, participants will be monitored for major adverse cardiovascular events over a median follow-up of up to 4.5 years, extending to 3 years after the last patient is enrolled. Researchers will track safety and efficacy outcomes through regular assessments to understand the benefits and risks of the treatment approaches. The study enrollment includes adults aged 40 years and older who meet specific cholesterol and coronary calcium criteria.
CONDITIONS
Official Title
High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject must be at least 40 years of age.
- Asymptomatic patients with presence of coronary calcification (Agatston Score 64 100)
- Low-density lipoproteins cholesterol (LDL-C) <190 mg/dL
You will not qualify if you...
- Objective evidence of at least moderate inducible ischemia requiring revascularization treatment
- History of cerebrovascular disease
- History of coronary or peripheral arterial revascularization
- Active liver disease or persistent unexplained serum transaminase elevations more than 2 times the upper limit of normal range
- History of any adverse drug reaction requiring discontinuation of statin (e.g., rhabdomyolysis)
- Allergy or sensitivity to any statin or ezetimibe
- Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine
- Pregnancy or breast feeding
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- Unwillingness or inability to comply with the procedures described in this protocol.
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Trial Site Locations
Total: 1 location
1
SamsungMedicalCenter
Seoul, South Korea, 06351
Actively Recruiting
Research Team
S
Seung-Hyuk Choi, MD
K
Ki Hong Choi, MD
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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