A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease
Status:
Active, not recruiting
Trial end date:
2022-01-17
Target enrollment:
Participant gender:
Summary
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).