Comparison of Intensive Lipid-Lowering Therapy With a Statin-Ezetimibe Combination (Without Aspirin) vs. Statin Monotherapy (With Aspirin) In Asymptomatic Patient With Coronary Artery Calcification
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• Adults aged 19 years and older
• Asymptomatic patients with significant coronary calcification (Agatston score ≥ 100) and no physiologically significant coronary artery disease (CAD)
‣ The coronary CT scan used to establish the CAC score must be performed within 3 years prior to randomization.
⁃ The assessment of physiological significance must be performed within 6 months prior to randomization
• Participants will be eligible for inclusion regardless of prior statin or anti-platelet agents use.
Locations
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Contact Information
Primary
Seung-Whan Lee
seungwlee@amc.seoul.kr
82230103170
Time Frame
Start Date:2025-07-09
Estimated Completion Date:2032-10-31
Participants
Target number of participants:7435
Treatments
Experimental: Intensive lipid-lowering therapy without aspirin
In this group, intensive lipid-lowering therapy is performed without aspirin using pitavastatin 4 mg/ezetimibe 10 mg, targeting patients with coronary artery calcification (Agatston score ≥100) who require primary prevention and do not have physiologically significant coronary artery disease.~◦ Intervention Medications: Pitavastatin 4 mg/ezetimibe 10 mg (aspirin excluded)
Active_comparator: Statin Monotherapy with Aspirin
IIn this group, moderate-intensity lipid-lowering therapy is administered using pitavastatin 2 mg and aspirin for patients with coronary artery calcification (Agatston score ≥100) who require primary prevention and do not have physiologically significant coronary artery disease.~◦ Intervention Medications: Pitavastatin 2 mg and aspirin (Based on the clinician's judgment, the statin dosage may be increased to pitavastatin 4 mg depending on the LDL response, and if there are adverse effects associated with aspirin, it can be replaced with clopidogrel.)