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Clinical Trial Summary

Experimental models have linked lipid lowering therapies with systemic inflammation; however, relatively little is known about this network in clinical populations and specifically how it changes with PCSK9 inhibition. The aim of the study is to define how PCSK9 inhibition alters the circulating monocyte populations and to systematically profile the transcriptional and proteomic responses to TLRS and how these responses are modulated by PCSK9 inhibition in the peripheral blood mononuclear cells (PBMC) clinical samples and relate these molecular signatures to clinical.

Clinical Trial Description

Multi-center, double-blind, randomized, placebo-controlled, parallel group Phase IV study with two treatment arms: evolocumab SC 420 mg/dL QM or matching placebo. The population will include 40 participants with documented CAD and type 2 diabetes who receive treatment with maximal tolerated statin therapy and stable doses of anti-hyperglycemic therapy.

Subjects will be followed for 12 weeks during the treatment phase, maintaining the double-blind throughout. Assessments of ACUTE and SHORT-TERM effects of PCSK9 inhibition with evolocumab on biocellular markers of endothelial function will be measured at baseline, Week 2, and Week 12. Safety assessments will be undertaken at each study visit. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03829046
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact Qinzhong Chen, MD
Phone (212) 659-8864
Status Not yet recruiting
Phase Phase 4
Start date April 1, 2019
Completion date October 2020

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