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)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
SamsungMedicalCenter
RECRUITING
Seoul
Contact Information
Primary
Seung-Hyuk Choi, MD
sh1214.choi@samsung.com
82-2-3410-3419
Backup
Ki Hong Choi, MD
cardiokh@gmail.com
82-2-3410-6653
Time Frame
Start Date: 2023-07-03
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 6000
Treatments
Experimental: Aggressive treatment arm
In this group, high-intensity statin (rosuvastatin 20mg) combined with ezetimibe 10 mg will be prescribed regardless of patients' age, concomitant diabetes mellitus, or ASCVD risk.
Active_comparator: Standard treatment arm
In this group, lipid lowering therapy will be followed according to the current guideline recommendation. A moderate-intensity statin (rosuvastatin 5 mg) will be prescribed for patients over 75 years of age or with diabetes mellitus. For non-diabetic patients aged 40-75 years, the use of statins will be determined by calculating the ASCVD risk score. (ASCVD risk \<7.5%: no statin use, ≥7.5 - \<20%: moderate-intensity statin \[rosuvastatin 5mg\], ≥ 20%: high-intensity statin \[rosuvastatin 20mg\])
Related Therapeutic Areas
Sponsors
Leads: Samsung Medical Center