Actively Recruiting
High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium
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
The aim of this study is to compare safety and efficacy between the aggressive treatment with combination of high-intensity statin and ezetimibe and the current standard lipid lowering treatment in asymptomatic patients with presence of coronary calcification.
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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
SamsungMedicalCenter
Seoul, South Korea, 06351
Actively Recruiting
Research Team
S
Seung-Hyuk Choi, MD
CONTACT
K
Ki Hong Choi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here