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

Part of paid clinical trials in New York, New York.

Sponsor
Robert Rosenson
Study ID
NCT03829046
Phase
PHASE4
Status
Completed

Conditions

  • Atherosclerotic Vascular Disease
  • Microvascular Dysfunction
  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    12 weeks of treatment
  • Evolocumab — DRUG
    12 weeks of treatment

Study Details

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.

Key Dates

Start date
Jun 3, 2019
Status verified
Apr 2026
Primary completion
Nov 15, 2021
Completion
Nov 15, 2021

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Placebo Comparator: Placebo
    Placebo SC QM
  • Active Comparator: Evolocumab
    Evolocumab SC 420mg/dL QM

Primary Outcome Measure

Number of Adverse Events [ Time Frame: up to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

Find similar trials in New York, NY

By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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