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COMPLETED
NCT03829046
PHASE4

The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease

Sponsor: Robert Rosenson

View on ClinicalTrials.gov

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 eligible subjects will have 6 visits in 13 to 16 weeks and will have Repatha/placebo 140mg subcutaneous every 4 weeks for 3 times since randomization visit, blood tests will be done in each visit to evaluate the effects of evolocumab upon biocellular markers potentially altered by PCSK9 inhibition in a population of type 2 diabetes patients with microvascular dysfunction. Primary Aims: Determine the ACUTE and SHORT-TERM effects of PCSK9 inhibition with evolocumab on biocellular markers of inflammation, immune mediated thrombosis and rheology. The data from this trial will be used to support a clinical trial to assess the role of PCSK9 inhibition in type 2 diabetes patients with cardiac microvascular dysfunction. Secondary Aims: 1. To define the association between PCSK 9 concentrations and immune-related phenotype. 2. To define the association between Lp(a) concentrations, oxidized phospholipids (OxPL), ApoB, biocellular markers of inflammation, tissue factor and immunothrombosis.

Official title: The Effects of Evolocumab on Endothelial and Inflammatory Biocellular Markers in Patients With Diabetes and Atherosclerotic Vascular Disease (METCHNIKOFF)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2019-06-03

Completion Date

2021-11-15

Last Updated

2026-04-28

Healthy Volunteers

No

Interventions

DRUG

Placebo

12 weeks of treatment

DRUG

Evolocumab

12 weeks of treatment

Locations (2)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

St. Michael's - University of Toronto

Toronto, Ontario, Canada