Icosapent Ethyl for High-Risk Coronary Plaques Assessed by 18F-NaF PET/CT
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChina National Center for Cardiovascular Diseases
About this trial
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.
Eligibility criteria
Qualifiers
Male or female participants aged 18 to 75 years.
Ability to understand the study and provide written informed consent before enrollment.
Receiving a stable lipid-lowering regimen before enrollment, with the type and dose of statin therapy remaining unchanged for at least 4 weeks.
Fasting triglyceride level below 5.6 mmol/L.
Disqualifiers
Current participation in another investigational drug, device, or procedure study, or receipt of an investigational drug or device within 4 weeks before enrollment.
Treatment with icosapent ethyl within 12 months before enrollment.
Known intolerance or hypersensitivity to icosapent ethyl or fish oil.
A previous diagnosis of homozygous familial hypercholesterolemia or hyperlipidemia requiring hemodialysis.
Trial design
Treatments tested in this trial
- icosapent ethyl (IPE)
- Standard LDL-C-Lowering Therapy
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
China National Center for Cardiovascular Diseases
Lead sponsor
Beijing Anzhen Hospital
Collaborator
Beijing Chao Yang Hospital
Collaborator
Beijing Municipal Health Commission
Collaborator
Source ClinicalTrials.gov