High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium
Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination Versus StanDard carE in AsymptomatiC PatIentS wIth Presence of COroNary Artery CALCIUM (DECISION-CAL)
Samsung Medical Center
6,000 participants
Jul 3, 2023
INTERVENTIONAL
Conditions
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 Criteria3
- 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 Criteria10
- 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.
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Interventions
At least moderate intensity statin, recommended by the current guideline based on the ASCVD risk
Rosuvastatin 20 mg + Ezetimibe 10 mg
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05845424