KCT0008541
Not yet recruiting
未知
Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination versus StanDard carE in AsymptomatiC PatIentS wIth Presence of COroNary Artery CALCIUM
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Samsung Medical Center
- Enrollment
- 6000
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subject must be at least 40 years of age.
- •2\.Asymptomatic patients with presence of coronary calcification (Agatston Score \= 100\)
- •3\.low\-density lipoproteins cholesterol (LDL\-C) \<190 mg/dL
- •4\.A subject who voluntarily signed the Informed consent form
Exclusion Criteria
- •1\.Objective evidence of at least moderate inducible ischemia requiring revascularization treatment
- •2\.History of cerebrovascular disease
- •3\.History of coronary or peripheral arterial revascularization
- •4\.Active liver disease or persistent unexplained serum transaminase elevations more than 2 times the upper limit of normal range
- •5\.History of any adverse drug reaction requiring discontinuation of statin (e, g. rhabdomyolysis)
- •6\.Allergy or sensitivity to any statin or ezetimibe
- •7\.Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine
- •8\.Pregnancy or breast feeding
- •9\.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)
- •10\.Unwillingness or inability to comply with the procedures described in this protocol.
Outcomes
Primary Outcomes
Not specified
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