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

• Status: Not yet recruiting
• Trial end date: 2030-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Ezetimibe; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Criteria

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.