Effect of Evolocumab on Coronary Plaque Characteristics

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

Sponsor
Annapoorna Kini
Study ID
NCT04710368
Phase
PHASE4
Status
Completed

Conditions

  • Coronary Artery Disease

Eligibility Criteria

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

Interventions

  • Evolocumab Injections — DRUG
    Administered on day 1 (the day of the first treatment) and through week 26 with a personal injector or prefilled auto injector/pens.

Study Details

The aim of the study is to assess the effect of evolocumab on coronary plaque morphology using intravascular imaging and gene expression analysis of peripheral blood mononuclear cells (PBMC) in patients with stable CAD on maximally tolerated statin therapy. The study combines multi-modality intravascular imaging approaches and transcriptomic based machine learning algorithms to uncover molecular mechanisms responsible for the beneficial changes in atherosclerotic lesions of patients treated with evolocumab. The primary end-points are the changes from baseline to follow-up in (1) the minimal fibrous cap thickness (FCT) assessed by optical coherence tomography (OCT) and (2) maxLCBI4mm assessed by near-infrared spectroscopy (NIRS) after 26 weeks of evolocumab. The secondary endpoints are the changes in (1) the maximal lipid arc, lipid length, lipid volume index, macrophage accumulation and calcification by OCT; (2) PAV and TAV defined by intravascular ultrasound (IVUS) and (3) Changes in PBMC gene expression.

Key Dates

Start date
May 4, 2021
Status verified
Nov 2023
Primary completion
Oct 28, 2022
Completion
Nov 6, 2023

Study Design

Enrollment
137 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment
    Evolocumab subcutaneously administered 140 mg every 2 weeks for 26 weeks

Primary Outcome Measure

Change in Minimal Fibrous Cap Thickness (FCT) [ Time Frame: Baseline and 26 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029-

Find similar trials in New York, NY

By research site
Mount Sinai Hospital· New York, NY

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