CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Evolocumab 140 MG/ML [Repatha] +1 moredrug
Likely dose
Evolocumab 140 MG/ML [Repatha]from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04141579
NCT04141579N/ACompleted

Functional Improvement of Non-infarcT relaTed Coronary Artery Stenosis by Extensive LDL-C Reduction With a PCSK9 Antibody

Radboud University Medical Center·interventional·Posted Oct 28, 2019·Updated Jul 18, 2024

In Brief

A clinical study evaluating Evolocumab 140 MG/ML [Repatha] and Placebo for Coronary Artery Disease and Atherosclerosis of Coronary Artery. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
CollaboratorsAmgen

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 28, 2019
Enrollment StartNov 10, 2020
Primary CompletionNov 9, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.7 years ago

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).

Placebodrug

Matching placebo