A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Virginia
Study ID
NCT02959047
Phase
PHASE4
Status
Completed

Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
35 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    150mg SQ every 2 weeks
  • Matching placebo — DRUG
    SQ every 2 weeks

Study Details

Peripheral arterial disease (PAD) is characterized by lower limb arterial obstruction due to atherosclerosis. Magnetic resonance imaging (MRI) methods can accurately quantify atherosclerotic plaque in the superficial femoral artery (SFA) in patients with PAD. Such techniques have demonstrated plaque regression with statin therapy over 1 year. Alirocumab is a PCSK9 inhibitor that effectively reduces LDL cholesterol up to 70% in patients on statins or intolerant to statins. The investigators hypothesize that effective low density lipoprotein (LDL) lowering with Alirocumab 150m subcutaneously (SQ) every 2 weeks will regress atherosclerotic plaque in the SFA in patients with PAD over one year compared to placebo. 54 patients with mild-moderate PAD (ankle brachial index or ABI 0.4-0.9) will be randomized to alirocumab 150 mg SQ every 2 weeks or matching placebo at the University of Virginia (UVA) (n=34) and Northwestern (n=20). The primary endpoint is change in atherosclerotic plaque volume in the superficial femoral artery over the 1 year treatment period. Secondary endpoints include changes in peak calf muscle perfusion after thigh cuff occlusion/hyperemia, 6-minute walk distance, and blood biomarkers (LDL cholesterol, fibrinogen, high sensitivity c-reactive protein (hs-CRP), and lipoprotein(a).

Key Dates

Start date
Jul 17, 2017
Status verified
May 2023
Primary completion
May 8, 2023
Completion
May 8, 2023

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alirocumab
    Alirocumab 150mg SQ every 2 weeks
  • Placebo Comparator: Placebo
    Matched placebo

Primary Outcome Measure

Change in superficial femoral plaque volume (summed from both legs) [ Time Frame: 1 year ]

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
University of Virginia Health SystemCharlottesvilleVirginia22908-

Find similar trials in Chicago, IL

By research site
Northwestern University· Chicago, ILUniversity of Virginia Health System· Charlottesville, VA

Related Studies