Effect of Evolocumab in people at risk of strokes

Phase 1

• Conditions: Carotid stenosis; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-001234-18-GB
• Lead Sponsor: Imperial College NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-24
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 70

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 =1.8 mmol/L (70 mg/dL)
•On stable dose of maximally-tolerated lipid-lowering therapy in accordance with UK national clinical guidelines (NICE CG181) for =2 months prior to screening. Acceptable non-statin lipid-lowering medications include ezetimibe or a fibrate.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

•Any medical condition which, in the opinion of the investigators, would present an unacceptable risk to the patient 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 IMP 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified