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Rosuvastatin and Evolocumab for Coronary Artery Disease — Yellow V  

Coronary Artery Disease Clinical Trial

Official title:
Effect of Statins and Evolocumab on Peripheral Blood Mononuclear Cell Gene Expression in Patients With Coronary Artery Disease: Yellow V

Clinical Trial Summary

The aim of the retrospective study is to characterize the molecular mechanisms responsible for the effect of statins and evolocumab in patients with stable coronary artery disease. The research team will retrieve and review intravascular imaging and gene expression data previously collected in the catheterization laboratory during the following time-period: 8/1/2013-4/14/2015 and 5/4/2021 - 10/28/2022.

Clinical Trial Description

The researchers will use the previously collected transcriptomic and intravascular imaging data collected from subjects between 8/1/2013-4/14/2015 (statin group) and subjects who participated in YELLOW III study (evolocumab group). The analyses will allow us detect common and unique pathways for each drug. The researchers will use intravascular imaging findings (optical coherence tomography, OCT) to characterize patient's individual response to treatment as beneficial, if OCT fibrous cap thickness (FCT) increased at follow-up and develop machine-learning models to predict the individual response using baseline gene expression. The researchers hypothesize that the analyses will uncover unique gene panels predicting beneficial response to statin and evolocumab allowing to select the best treatment approach for an individual patient. The total number of subjects will be 195. Transcriptomic profile of PBMC at baseline and follow-up will be compared between the groups to establish the common and distinctive molecular mechanisms of the effect of statins and evolocumab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05984953
Study type Observational
Source Icahn School of Medicine at Mount Sinai
Contact
Status Completed
Phase
Start date August 1, 2013
Completion date October 28, 2022
View Details
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