Rosuvastatin and Evolocumab for Coronary Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-01

Study Completion Date

2022-10-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Statin

85 patients treated with statin

statin

Intervention Type DRUG

40 mg of rosuvastatin daily for 8-12 weeks

Evolocumab

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

statin

Intervention Type DRUG

40 mg of rosuvastatin daily for 8-12 weeks

evolocumab

Intervention Type DRUG

140 mg evolocumab every 2 weeks (26 weeks)

Interventions

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statin

40 mg of rosuvastatin daily for 8-12 weeks

Intervention Type DRUG

evolocumab

140 mg evolocumab every 2 weeks (26 weeks)

Intervention Type DRUG

Eligibility Criteria

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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