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

Qualifiers

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

Treatments tested in this trial

  • Guideline directed statin therapy
  • High intensity statin plus ezetimibe therapy

Treatment groups

6,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators