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Completed

NCT Number: NCT05984953

Rosuvastatin and Evolocumab for Coronary Artery Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai Hospital

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with coronary artery disease who underwent cardiac catheterization with or without PCI
  • Patients from 8/1/2013-4/14/2015 and YELLOW III with both visits available, baseline and follow-up

Exclusion criteria

  • patients from 8/1/2013-4/14/2015 and YELLOW III lost to follow-up

Treatment and study plan

Statin

Drug

40 mg of rosuvastatin daily for 8-12 weeks

Evolocumab

Drug

140 mg evolocumab every 2 weeks (26 weeks)

Primary outcomes

  1. Expression levels of mRNA in blood cells

    Time frame: 18 month

    Expression levels of mRNA in blood cells of the patients to be measured to identify the genes which are associated with a beneficial response to treatment using transcriptomic analysis of PBMC to find the key genes (biomarkers) responsible for effective therapy.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Acronym: Yellow V

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2023
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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