Rosuvastatin and Evolocumab for Coronary Artery Disease (Yellow V)

Mount Sinai Health System

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Drug: evolocumab; Drug: statin

Study type: Observational

Funder types: Other

Identifiers

NCT05984953

STUDY-22-01743

Details and patient eligibility

About

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.

Full 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.

Enrollment: 195 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

195 participants in 2 patient groups

Statin

Description:

85 patients treated with statin

Treatment:

Drug: statin

Evolocumab

Description:

110 patients treated with evolocumab in addition to statin or evolocumab alone

Treatment:

Drug: statin

Drug: evolocumab