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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
icosapent ethyl (IPE)
DrugIcosapent 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
DrugParticipants 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Icosapent Ethyl Plus Standard LDL-C-Lowering TherapyExperimental treatment 2 interventions
Group B: Standard LDL-C-Lowering Therapy AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Absolute Change From Baseline in Maximum Target-to-Background Ratio of the Target Coronary Lesion
The target lesion is defined as the coronary lesion with the highest maximum target-to-background ratio (TBRmax) at baseline. TBRmax is calculated as the maximum standardized uptake value (SUVmax) of the target lesion divided by the mean standardized uptake value (SUVmean) of the blood-pool background measured in the right atrium, superior vena cava, or inferior vena cava. Absolute change is calculated as the Month 12 TBRmax minus the baseline TBRmax.
Time frame
Baseline and Month 12Secondary outcomes
1
Percentage Change From Baseline in TBRmax of the Target Coronary Lesion
The target lesion is the coronary lesion with the highest TBRmax at baseline. Percentage change is calculated as \[(Month 12 TBRmax - baseline TBRmax) / baseline TBRmax\] × 100%.
Time frame
Baseline and Month 122
Change From Baseline in SUVmax of the Target Coronary Lesion
Change in the maximum standardized uptake value of the prespecified target coronary lesion, calculated as the Month 12 value minus the baseline value.
Time frame
Baseline and Month 123
Change From Baseline in Total Volume of 18F-NaF-Positive Coronary Plaque
Total volume of coronary plaque demonstrating positive 18F-NaF uptake, defined as TBRmax greater than 1.25. Change is calculated as the Month 12 volume minus the baseline volume.
Time frame
Baseline and Month 124
Change From Baseline in the Number of 18F-NaF-Positive Coronary Segments
Number of coronary artery segments with positive 18F-NaF uptake, defined as TBRmax greater than 1.25. Change is calculated as the Month 12 count minus the baseline count.
Time frame
Baseline and Month 12Other outcomes
1
Change in Plasma triglycerides Levels From Baseline to Month 12
Plasma levels of triglycerides (TG) will be measured.
Time frame
Baseline and Month 122
Percentage Change From Baseline in Plasma High-Sensitivity C-Reactive Protein Level
Percentage change will be calculated as \[(Month 12 hs-CRP - baseline hs-CRP) / baseline hs-CRP\] × 100%.
Time frame
Baseline and Month 123
Change in Plasma Eicosapentaenoic Acid Level From Baseline to Month 12
Plasma eicosapentaenoic acid (EPA) concentration will be measured and reported in its applicable concentration unit (e.g., μg/mL or % of total fatty acids, according to the laboratory assay).
Time frame
Baseline and Month 124
Exploratory Incidence of Three-Point Major Adverse Cardiovascular Events
Number and percentage of participants experiencing a three-point major adverse cardiovascular event (3P-MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or nonfatal stroke.
Time frame
From randomization through Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
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