High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium

Summary

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.

Eligibility

Inclusion Criteria:

* Subject must be at least 40 years of age.
* Asymptomatic patients with presence of coronary calcification (Agatston Score ≥ 100)
* low-density lipoproteins cholesterol (LDL-C) \<190 mg/dL

Exclusion Criteria:

* 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.

Conditions4

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