Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Westside Medical Associates of Los Angeles
Study ID
NCT02992301
Phase
PHASE4
Status
Unknown

Conditions

  • Atherosclerosis
  • Hyperlipidemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Alirocumab — DRUG
    Injectable prescription medicine called a PCSK9 inhibitor.

Study Details

Aim 1: To determine whether therapy with Alirocumab, compared to pre-treatment, will effectively improve carotid atherosclerotic plaque characteristics by reducing Ktrans and LRNC size. To achieve this goal, we will (a) enroll 30 subjects who are intolerant to high intensity statin therapy and only able to tolerate low potency statin or low weekly dose of high potency statin and have LDL-C ≥70 mg/dl; (b) initiate alirocumab at 150mg subcutaneously injection every 2 weeks; (c) perform carotid DCE-MRI scans at baseline, 3, 6 and 12 months; (d) perform quantitative analysis for vascular inflammation and plaque LRNC volume and other plaque characteristics; (e) compare vascular inflammation and LRNC volume between pre- and post-alirocumab at 3, 6 and 12 months. Aim 2: To examine associations between reductions in atherogenic lipids (LDL-C, Lp(a), non-HDL-C) and changes in atherosclerotic plaque characteristics. To achieve this goal, we will (a) perform laboratory assessments of lipids, lipoproteins and apo-lipoproteins at baseline and during the study; (b) compare lipids, lipoproteins and apo-lipoproteins levels between pre- and post-alirocumab; (c) correlate reductions in atherogenic lipids with changes atherosclerotic plaque characteristics.

Key Dates

Start date
Nov 30, 2016
Status verified
Apr 2019
Primary completion
Nov 30, 2019
Completion
Nov 30, 2019

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open Label
    All enrolled patients will receive open label Praluent (Alirocumab).

Primary Outcome Measure

Changes in carotid atherosclerotic plaque characteristics as evidenced by effect on the volume transfer constant( Ktrans) and lipid-rich necrotic core (LRNC) size. [ Time Frame: 52 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Westside Medical Associates of Los AngelesBeverly HillsCalifornia90211-

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By research site
Westside Medical Associates of Los Angeles· Beverly Hills, CA

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