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

NCT04141579 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-07-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Evolocumab 140 MG/ML [Repatha]

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).

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2023-11-09
Completion
2023-11-09

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141579 on ClinicalTrials.gov