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Icosapent Ethyl for High-Risk Coronary Plaques Assessed by 18F-NaF PET/CT
Sponsor: China National Center for Cardiovascular Diseases
Summary
This randomized controlled study will evaluate whether icosapent ethyl (IPE) can improve and stabilize high-risk coronary plaques in patients receiving stable low-density lipoprotein cholesterol (LDL-C)-lowering therapy. Potential participants will have coronary plaques identified by coronary computed tomography angiography (CCTA), with 30% to 70% narrowing in at least one major coronary artery and at least one high-risk plaque feature. After baseline imaging with fluorine-18 sodium fluoride positron emission tomography/computed tomography (18F-NaF PET/CT), eligible participants will be randomly assigned in a 1:1 ratio to receive either IPE 2 g twice daily plus standard LDL-C-lowering therapy or standard LDL-C-lowering therapy alone for 12 months. At the end of treatment, participants will undergo repeat CCTA and 18F-NaF PET/CT. Blood biomarkers and major adverse cardiovascular events will also be assessed during follow-up.
Official title: A Randomized Controlled Trial Evaluating the Effect of Icosapent Ethyl on High-Risk Coronary Plaques Using 18F-Sodium Fluoride PET/CT
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-08-01
Completion Date
2029-12-31
Last Updated
2026-08-13
Healthy Volunteers
No
Interventions
icosapent ethyl (IPE)
Icosapent ethyl will be administered orally at a dose of 2 g twice daily (total daily dose of 4 g) for 12 months, in addition to stable LDL-C-lowering therapy.
Standard LDL-C-Lowering Therapy
Participants will continue an individualized, stable LDL-C-lowering regimen throughout the 12-month study period. The LDL-C-lowering regimen must have remained stable for more than 4 weeks before randomization. This background therapy will be administered in both study arms.
Locations (1)
Fuwai Hospital
Beijing, Beijing Municipality, China