NCT03931161

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

Effect of Evolocumab on Carotid Plaque Composition in Asymptomatic Carotid Artery Stenosis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Imperial College Healthcare NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
DRUG	Evolocumab Auto-Injector [Repatha]	Auto-Injector, 140 mg every two weeks.
DRUG	Placebo Auto-Injector	Matching Placebo for the active comparator (Evolocumab)

Timeline

• Start date: 2019-09-04
• Primary completion: 2023-05-06
• Completion: 2024-05-06
• First posted: 2019-04-30
• Last updated: 2022-10-13

Locations

1 site across 1 country: United Kingdom