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

Launched by SAMSUNG MEDICAL CENTER · Apr 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a combination of high-intensity statin medication and ezetimibe can better lower cholesterol levels and improve heart health compared to the standard treatment for patients who show signs of coronary artery calcification but have no symptoms. Specifically, the trial is looking for participants who are at least 40 years old, have a certain level of coronary calcification, and whose bad cholesterol (LDL) is below 190 mg/dL.

If you join this trial, you will be monitored closely to see how well this more aggressive treatment works and whether it is safe for you. It's important to note that there are some conditions that would exclude you from participating, such as a history of heart surgery or certain liver issues. The study is currently recruiting participants, and anyone interested should discuss with their healthcare provider to see if they qualify. Your involvement could help improve treatment options for people at risk of heart disease.

Gender

ALL

Eligibility 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.