Rosuvastatin and Evolocumab for Coronary Artery Disease

NCT05984953 | Completed

• 1 other identifier: STUDY-22-01743
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Expression levels of mRNA in blood cells

  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.

  18 month

Study Arms (2)

Statin

85 patients treated with statin

Drug: statin

Evolocumab

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

Drug: statin; Drug: evolocumab

Interventions

statin DRUG

40 mg of rosuvastatin daily for 8-12 weeks

Evolocumab; Statin

evolocumab DRUG

140 mg evolocumab every 2 weeks (26 weeks)

Evolocumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with coronary artery disease who underwent cardiac catheterization with or without PCI

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; evolocumab

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Annapoorna Kini, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: August 9, 2023
• Study Start: August 1, 2013
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. To achieve aims in the approved proposal. Proposals should be directed to annapoorna.kini@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link tbd).

Locations

US (1)