Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination versus StanDard carE in AsymptomatiC PatIentS wIth Presence of COroNary Artery CALCIUM
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008541
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 6000
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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rates of major adverse cardiac and cerebrovascular events
- Secondary Outcome Measures
Name Time Method Coronary calcium progression at follow-up (delta Agatston Score per year);Proportion of patients with LDL-C <100 mg/dL ;Proportion of patients with LDL-C <70 mg/dL ;Changes of LDL-C ;Proportion of discontinuation or dose-reduction of study drug by intolerance at 3 years;New-onset diabetes mellitus;Hepatic disorder requiring discontinuation of statin;Muscle-related adverse events (muscle pain, myopathy, and rhabdomyolysis);Gastrointestinal symptoms (dyspepsia or abdominal pain not explainable with other cause);Bleeding (Bleeding Academic Research Consortium type 2-5) ;All-cause death;Cardiac death;Myocardial infarction;Stroke;Unplanned coronary revascularization;Arterial revascularization procedure;Heart failure hospitalization