NCT03931161

Brief Summary

This is a phase IV, randomised, placebo-controlled, double-blind, parallel group study to determine the effect of Evolocumab treatment on carotid plaque morphology and composition in asymptomatic patients with \>50% carotid artery stenosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 4, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2024

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

3.7 years

First QC Date

April 15, 2019

Last Update Submit

October 12, 2022

Conditions

Carotid Artery Stenosis

Keywords

carotid plaque morphologycarotid plaque compositionevolocumab

Outcome Measures

Primary Outcomes (1)

  • Change in lipid-rich necrotic core

    Change in lipid-rich necrotic core (LRNC) size at 12 months, compared to baseline

    12 months

Secondary Outcomes (9)

  • Percentage of LRNC core

    12 months

  • LRNC regression

    12 months

  • LRNC volume

    24 months

  • LRNC percentage

    24 months

  • Measures of other carotid plaque burden - Volume wall thickness

    24 months

  • +4 more secondary outcomes

Other Outcomes (12)

  • Exploratory outcomes 1: Change in biochemical parameters - total cholesterol

    24 months

  • Exploratory outcomes 1: Change in biochemical parameters - LDL-C

    24 months

  • Exploratory outcomes 1: Change in biochemical parameters - HDL-C

    24 months

  • +9 more other outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching Placebo.

Drug: Placebo Auto-Injector

Evolocumab

ACTIVE COMPARATOR

Evolocumab Auto-Injector \[Repatha\]

Drug: Evolocumab Auto-Injector [Repatha]

Interventions

Evolocumab Auto-Injector [Repatha]DRUG

Auto-Injector, 140 mg every two weeks.

Also known as: Repatha
Evolocumab
Placebo Auto-InjectorDRUG

Matching Placebo for the active comparator (Evolocumab)

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Sufficient English language ability to adequately understand the study
  • Able to give informed consent
  • Significant carotid artery plaque with 50-70% stenosis on ultrasound or MRI performed prior to screening
  • Significant asymptomatic carotid artery plaque with \>70% stenosis on ultrasound or MRI performed prior to screening, but carotid endarterectomy or carotid artery stenting has been deemed unsuitable by multidisciplinary team during routine clinical care
  • Lipid-rich necrotic core (LRNC) on baseline MRI scan
  • Adequate image quality for MRI analysis.
  • LDL-C ≥2.6 mmol/L (100 mg/dL)
  • On stable dose of maximally-tolerated lipid-lowering therapy in accordance with UK national clinical guidelines (NICE CG18120) for ≥2 months prior to screening. Acceptable non-statin lipid-lowering medications include ezetimibe or a fibrate.

You may not qualify if:

  • Any medical condition which, in the opinion of the investigators, would present an unacceptable risk to the participant if they were to take part in the trial, or prevent them from following the trial protocol
  • Current or previous treatment with a PCSK9 inhibitor
  • Eligible for PCSK9 inhibitor treatment under current NICE guidelines
  • Contra-indication to or inability to use Evolocumab treatment, including:
  • Sensitivity to Evolocumab or any associated excipients
  • Unable to tolerate or perform self-administration of Evolocumab by auto-injector
  • Lack of suitable refrigerated storage
  • Contra-indication to or inability to tolerate MRI
  • Estimated glomerular filtration rate (eGFR) ≤45 mL/min/1.73 m2 prior to MRI scan
  • Pregnancy or breast-feeding
  • Women of childbearing potential who are unwilling or unable to use a highly effective method of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jaimini Cegla, BSc MSc MBBS MRCP FRCPath PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 30, 2019

Study Start

September 4, 2019

Primary Completion

May 6, 2023

Study Completion

May 6, 2024

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)