Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination versus StanDard carE in AsymptomatiC PatIentS wIth Presence of COroNary Artery CALCIUM

Samsung Medical Center0 个研究点目标入组 6,000 人开始时间: 待定最近更新: 2023年6月26日

适应症

试验速览

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•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.

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