CClinicalTrials.gg
Sign In
Status unknownNCT03931161EVOCAR-1Updated Oct 13, 2022

Effect of Evolocumab on Carotid Plaque Composition in Asymptomatic Carotid Artery Stenosis (EVOCAR-1)

A Phase 4 interventional study of Evolocumab Auto-Injector [Repatha] and Placebo Auto-Injector in Carotid Artery Stenosis, sponsored by Imperial College Healthcare NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-13.

Sponsored by Imperial College Healthcare NHS Trust · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

In this study patients will be randomised in a 1:1 ratio to receive Evolocumab 140 mg every two weeks or matching placebo, to be administered for 12 months. After 12 months of treatment, patients will remain in follow-up for a further 12 months.

High resolution magnetic resonance imaging (MRI) will be used to serially monitor the impact of Evolocumab on carotid plaque morphology and composition in patients with significant carotid stenosis who do not meet clinical criteria for carotid endarterectomy. This approach will reveal if clinically beneficial plaque regression occurs, without requiring the large patient cohorts or long follow-up needed for cardiovascular outcome trials.

Results from this study will establish whether treatment with Evolocumab is likely to be beneficial to patients with asymptomatic carotid stenosis.

02

Conditions studied

  • Carotid Artery Stenosis

Keywords

  • carotid plaque morphology
  • carotid plaque composition
  • evolocumab
03

In context

Carotid Stenosis

339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.

This study's enrollment of 33 is below the median of 106 across 182 interventional studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

Imperial College Healthcare NHS Trust is the lead sponsor of 79 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Matching Placebo.

    Drug: Placebo Auto-Injector

  • Active comparator
    Evolocumab

    Evolocumab Auto-Injector \[Repatha\]

    Drug: Evolocumab Auto-Injector [Repatha]

Interventions

  • DrugEvolocumab Auto-Injector [Repatha]

    Auto-Injector, 140 mg every two weeks.

    Also known as: Repatha

  • DrugPlacebo Auto-Injector

    Matching Placebo for the active comparator (Evolocumab)

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Change in lipid-rich necrotic core

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

    Time frame: 12 months

Secondary outcomes

  1. Percentage of LRNC core

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

    Time frame: 12 months

  2. LRNC regression

    Percentage of participants achieving LRNC regression at 12 months

    Time frame: 12 months

  3. LRNC volume

    Change in carotid plaque LRNC volume at other time-points, compared to baseline

    Time frame: 24 months

  4. LRNC percentage

    Change in carotid plaque LRNC percentage at other time-points, compared to baseline

    Time frame: 24 months

  5. Measures of other carotid plaque burden - Volume wall thickness

    Absolute and percentage change, compared to baseline, of volume wall thickness

    Time frame: 24 months

  6. Measures of other carotid plaque burden - Volume wall area

    Absolute and percentage change, compared to baseline, volume wall area

    Time frame: 24 months

  7. Measures of other carotid plaque burden - Calcification

    Absolute and percentage change, compared to baseline, of plaque composition (calcification)

    Time frame: 24 months

  8. Measures of other carotid plaque burden - Fibrous tissue volume

    Absolute and percentage change, compared to baseline, of plaque composition (fibrous tissue volume)

    Time frame: 24 months

  9. Measures of other carotid plaque burden - New intra-plaque haemorrhage

    Absolute and percentage change, compared to baseline, of plaque composition (new intra-plaque haemorrhage)

    Time frame: 24 months

Other outcomes

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

    Absolute and percentage change compared to baseline in total cholesterol.

    Time frame: 24 months

  2. Exploratory outcomes 1: Change in biochemical parameters - LDL-C

    Absolute and percentage change compared to baseline in LDL-C.

    Time frame: 24 months

  3. Exploratory outcomes 1: Change in biochemical parameters - HDL-C

    Absolute and percentage change compared to baseline in high density lipoprotein-associated cholesterol (HDL-C).

    Time frame: 24 months

  4. Exploratory outcomes 1: Change in biochemical parameters - triglycerides

    Absolute and percentage change compared to baseline in triglycerides.

    Time frame: 24 months

  5. Exploratory outcomes 1: Change in biochemical parameters - lipoprotein (a)

    Absolute and percentage change compared to baseline in lipoprotein(a).

    Time frame: 24 months

  6. Exploratory outcomes 2: Number of patients with Cardio & cerebrovascular events - Ischaemic and non-ischaemic stroke

    Cardio- and cerebrovascular events \[be adjudicated by the Investigators\], including: Ischaemic and non-ischaemic stroke

    Time frame: 24 months

  7. Exploratory outcomes 2: Number of patients with Cardio & cerebrovascular events - TIA

    Cardio- and cerebrovascular events \[be adjudicated by the Investigators\], including: Transient ischaemic attack

    Time frame: 24 months

  8. Exploratory outcomes 2: Number of patients with Cardio & cerebrovascular events - Progression to carotid endarterectomy

    Cardio- and cerebrovascular events \[be adjudicated by the Investigators\], including: Progression to carotid endarterectomy

    Time frame: 24 months

  9. Exploratory outcomes 2: Number of patients with Cardio & cerebrovascular events - MI

    Cardio- and cerebrovascular events \[be adjudicated by the Investigators\], including: Myocardial infarction

    Time frame: 24 months

  10. Exploratory outcomes 2: Number of patients with Cardio & cerebrovascular events - Unstable angina

    Cardio- and cerebrovascular events \[be adjudicated by the Investigators\], including: Unstable angina

    Time frame: 24 months

  11. Exploratory outcomes 2: Number of patients with Cardio & cerebrovascular events - Hospitalisation for heart failure

    Cardio- and cerebrovascular events \[be adjudicated by the Investigators\], including: Hospitalisation for heart failure

    Time frame: 24 months

  12. Exploratory outcomes 2: Number of patients with Cardio & cerebrovascular events -PAD-related end points: peripheral revascularization,

    Cardio- and cerebrovascular events \[be adjudicated by the Investigators\], including: PAD-related end points: peripheral revascularization,

    Time frame: 24 months

07

Study locations

1 site
  • Imperial College Healthcare NHS Trust
    London, W12 0HS, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03931161
Lead sponsor
Imperial College Healthcare NHS Trust
Collaborators
Imperial College London
Responsible party
Sponsor
First posted
Apr 30, 2019
Start date
Sep 4, 2019
Primary completion
May 6, 2023 (estimated)
Completion
May 6, 2024 (estimated)
Last update
Oct 13, 2022

Study contacts

Jaimini Cegla, BSc MSc MBBS MRCP FRCPath PhD
principal investigator · Imperial College London

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carotid Stenosis→

Other studies from this sponsor

Imperial College Healthcare NHS Trust

Start the discussion