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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Auto-Injector, 140 mg every two weeks.
Matching Placebo for the active comparator (Evolocumab)
Imperial College Healthcare NHS Trust
London, United Kingdom
Change in lipid-rich necrotic core
Change in lipid-rich necrotic core (LRNC) size at 12 months, compared to baseline
Time frame: 12 months
Percentage of LRNC core
Change in percentage lipid-rich necrotic core (LRNC) at 12 months, compared to baseline
Time frame: 12 months
LRNC regression
Percentage of participants achieving LRNC regression at 12 months
Time frame: 12 months
LRNC volume
Change in carotid plaque LRNC volume at other time-points, compared to baseline
Time frame: 24 months
LRNC percentage
Change in carotid plaque LRNC percentage at other time-points, compared to baseline
Time frame: 24 months
Measures of other carotid plaque burden - Volume wall thickness
Absolute and percentage change, compared to baseline, of volume wall thickness
Time frame: 24 months
Measures of other carotid plaque burden - Volume wall area
Absolute and percentage change, compared to baseline, volume wall area
Time frame: 24 months
Measures of other carotid plaque burden - Calcification
Absolute and percentage change, compared to baseline, of plaque composition (calcification)
Time frame: 24 months
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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
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