High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorSamsung Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Guideline directed statin therapy
DrugAt least moderate intensity statin, recommended by the current guideline based on the ASCVD risk
High intensity statin plus ezetimibe therapy
DrugRosuvastatin 20 mg + Ezetimibe 10 mg
Treatment groups
6,000 Participants
are divided into 2 treatment groupsGroup A: Aggressive treatment armExperimental treatment 1 intervention
Group B: Standard treatment armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Major adverse cardiovascular events
a composite of death from any causes, myocardial infarction, stroke, unplanned coronary revascularization, or other arterial revascularization procedure
Time frame
up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)Secondary outcomes
1
All-cause death
Death from any causes
Time frame
up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)2
Cardiovascular death
Death from cardiovascular causes
Time frame
up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)3
Stroke
Ischemic or hemorrhagic stroke
Time frame
up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)4
Unplanned coronary revascularization
revascularization procedure to coronary artery
Time frame
up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)Sponsors and contacts
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Source ClinicalTrials.gov