Effect of Evolocumab on Coronary Plaque Characteristics (YELLOW III)
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|ClinicalTrials.gov Identifier: NCT04710368|
Recruitment Status : Active, not recruiting
First Posted : January 14, 2021
Last Update Posted : March 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Evolocumab Injections||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The study team will screen patients scheduled for elective PCI, who are receiving statin therapy for at least 4 weeks with acceptable LDL-C levels. Patients with non-obstructive lesion (30-50% stenosis) by angiography and lipid-rich plaque with lipid arc >90° and minimal fibrous cap thickness ≤ 120 µm detected by OCT will comprise the final study population. Serial NIRS/IVUS and OCT imaging will be performed in a non-target lesions, first during PCI and subsequently after 26 weeks.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Evolocumab on Coronary Plaque Characteristics: a Multimodality Imaging Study|
|Actual Study Start Date :||May 4, 2021|
|Actual Primary Completion Date :||October 28, 2022|
|Estimated Study Completion Date :||October 2023|
Evolocumab subcutaneously administered 140 mg every 2 weeks for 26 weeks
Drug: Evolocumab Injections
Administered on day 1 (the day of the first treatment) and through week 26 with a personal injector or prefilled auto injector/pens.
Other Name: Repatha
- Change in Minimal Fibrous Cap Thickness (FCT) [ Time Frame: Baseline and 26 Weeks ]Changes in the minimal Minimal Fibrous Cap Thickness (FCT) is assessed by Optical Coherence Tomography (OCT) imaging and measured in microns. FCT describes plaque morphology composition
- Change in maxNIRS4mm [ Time Frame: Baseline and 26 Weeks ]Changes in maxLCBI4mm. LCBI4mm is assessed by NIRS and calculated as the fraction of yellow pixels on a chemogram multiplied by 1000. Each pixel on the chemogram represents a probability of lipid presence in the given region; pixels are color-coded on a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow.
- Change in Maximal Lipid Arc [ Time Frame: Baseline and 26 Weeks ]Change in Maximal lipid arc assessed by OCT and measured in degrees.
- Change in Lipid Length [ Time Frame: Baseline and 26 weeks ]Change in Lipid length by OCT, measured in millimeters.
- Change in Lipid Volume Index (LVI) [ Time Frame: Baseline and 26 Weeks ]Change in Lipid Volume Length (LVI) calculated as the average lipid arc multiplied by lipid length assessed by OCT.
- Change in Macrophage Accumulation [ Time Frame: Baseline and 26 Weeks ]Change in the prevalence of Macrophage accumulation by OCT, a marker of inflammation (expressed as frequency of the presence of macrophages in lesions.)
- Change in Calcification accumulation [ Time Frame: Baseline and 26 Weeks ]Change in Calcification accumulation by OCT expressed as frequency of the presence of calcification in lesions.
- Change in Percent Atheroma Volume (PAV) [ Time Frame: Baseline and 26 weeks ]Change in PAV assessed by Intravascular Ultrasound (IVUS). PAV characterizes coronary plaque burden and calculated as the proportion of total vessel wall volume occupied by atherosclerotic plaque.
- Change in Total Atheroma Volume (TAV) [ Time Frame: Baseline and 26 Weeks ]Change in TAV assessed by IVUS. TAV characterizes the total volume of coronary plaque.
- Change in PBMC Gene Expression [ Time Frame: Baseline and 26 Weeks ]Change in PBMC gene expression. Messenger RNA sequencing data will be processed using statistical and bioinformatics analyses.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Men or women aged 18 years or older at screening who signed written Informed Consent
- Patients with coronary artery disease undergoing cardiac catheterization and PCI for a target lesion and also have a non-obstructive lesion (30-50% stenosis) identified by angiography
- Patients who are not candidates for PCI or CABG currently or over the next 12 months, in the opinion of the investigator
- Patients treated with statins for at least 4 weeks with LDL-C level ≥ 80 mg/dL for low- or moderate -intensity statin use and ≥ 60 mg/dL for high-dose statin. Patients with history of statin intolerance and LDL-C ≥ 100 mg/dL.
- Angiographic criteria: 30-50% reduction of lumen diameter in addition to the target lesion accessible by the OCT catheter. The target segment should not have a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), and may not be a bypass graft.
- OCT criteria: target segment should have a lipid-rich plaque with lipid arc >90° and fibrous cap thickness ≤120 µm.
- Women of childbearing potential must agree to be on an acceptable method of birth control/contraceptive
- Patients who have acute myocardial infarction (Q wave or non-Q wave with CK-MB > 5 times above the upper normal (31.5 ng/ml) within 72 hours)
- Patients who are in cardiogenic shock
- Patients with left main disease, in-stent restenotic lesions or patients requiring coronary artery bypass graft surgery
- Patients with elevated CK-MB (>6.3 ng/ml) or Tnl (>0.5 ng/ml)
- Patients with platelet count < 100,000 cell/mm3
- Patients who have co-morbidity which reduces life expectancy to one year
- Patients who are currently participating in another investigational drug/device study
- Patients with liver disease
- Patient with creatinine > 2.0 mg/dL
- Pregnant women and women of childbearing potential who intend to have children during the duration of the trial
- Patients having undergone heart transplantation, or those that may undergo heart transplantation during the study period
- Patients with active autoimmune disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04710368
|United States, New York|
|Mount Sinai Hospital|
|New York, New York, United States, 10029|
|Principal Investigator:||Annapoorna Kini, MD||Icahn School of Medicine at Mount Sinai|
|Responsible Party:||Annapoorna Kini, Professor of Medicine, Cardiology, Icahn School of Medicine at Mount Sinai|
|Other Study ID Numbers:||
|First Posted:||January 14, 2021 Key Record Dates|
|Last Update Posted:||March 10, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Coronary Artery Disease
Optical Coherence Tomography
Coronary Artery Disease
Arterial Occlusive Diseases
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents