EUCTR2018-001234-18-GBActive, not recruitingPhase 1
Effect of EVOlocumab on CARotid plaque composition in asymptomatic carotid artery stenosis (EVOCAR-1) - EVOCAR-1
Imperial College NHS Trust0 sites70 target enrollmentStarted: December 24, 2018Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 70
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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
Investigators
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