The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Robert Rosenson
Collaborators:
Amgen University of Michigan University of Toronto