Functional Improvement of Coronary Artery Narrowing by Cholesterol Reduction With a PCSK9 Antibody

Sponsor
Radboud University Medical Center
Study ID
NCT04141579
Status
Completed

Conditions

  • Atherosclerosis of Coronary Artery
  • Coronary Artery Disease

Eligibility Criteria

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

Interventions

  • Evolocumab 140 MG/ML [Repatha] — DRUG
    Evolocumab (also known as Repatha, formerly referred to as AMG 145) is a human monoclonal immunoglobulin G2 (IgG2) that specifically binds to proprotein convertase subtilisin/kexin type 9 (PCSK9) preventing its interaction with the low-density lipoprotein receptor (LDLR). The inhibition of PCSK9 by evolocumab leads to increased LDLR expression and subsequent decreased circulating concentrations of low-density lipoprotein cholesterol (LDL-C).
  • Placebo — DRUG
    Matching placebo

Study Details

In a large number of patients who experienced an acute coronary syndrome, multiple narrowings of the coronary arteries are identified. Mechanical treatment of the infarct related artery is indisputable, yet mechanical treatment of other bystander lesions in non-infarct related arteries is controversial. Low-density lipoprotein cholesterol can speed up the formation of these coronary artery narrowings, and can increase the risk of a second event. The investigators want to investigate if treating patients with the new cholesterol-lowering drug evolocumab in addition to statin therapy ameliorates blood flow and reduces atherosclerotic plaque size compared with placebo. Improved blood flow and a reduction of plaque size could prevent the need for additional stenting or surgery.

Key Dates

Start date
Nov 10, 2020
Status verified
Nov 2023
Primary completion
Nov 9, 2023
Completion
Nov 9, 2023

Study Design

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

Arms

  • Experimental: Treatment arm
    Evolocumab (140mg) will be administered subcutaneously every two weeks (Q2W) on day 1 through week 12 with personal injectors, containing 1 mL deliverable volume of 140 mg/mL Evolocumab.
  • Placebo Comparator: Comparator arm
    Placebo will be administered subcutaneously every two weeks (Q2W) on day 1 through week 12 with personal injectors, containing 1 mL deliverable volume of placebo.

Primary Outcome Measure

Change in FFR from baseline to follow-up in non-IRA lesions. [ Time Frame: FFR will be assessed at baseline (0 weeks) and at the last follow-up visit (12 weeks) ]

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