Effect of Evolocumab on Coronary Plaque Characteristics (YELLOW III)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04710368|
Recruitment Status : Not yet recruiting
First Posted : January 14, 2021
Last Update Posted : January 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Evolocumab Injections||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 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|
|Estimated Study Start Date :||February 2021|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2024|
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.
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
|Contact: Annapoorna Kini, MD||(212) email@example.com|
|Contact: Yuliya Vengrenyuk, PhD||(212) firstname.lastname@example.org|
|United States, New York|
|Mount Sinai Hospital|
|New York, New York, United States, 10029|
|Contact: Yuliya Vengrenyuk, PhD email@example.com|
|Principal Investigator: Annapoorna Kini, MD|
|Principal Investigator:||Annapoorna Kini, MD||Icahn School of Medicine at Mount Sinai|