EVOCAR-1
Research type
Research Study
Full title
Effect of EVOlocumab on CARotid plaque composition in asymptomatic carotid artery stenosis (EVOCAR-1)
IRAS ID
245920
Contact name
Jaimini Cegla
Contact email
Sponsor organisation
Imperial College London / Imperial College Healthcare NHS Trust
Eudract number
2018-001234-18
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
When “plaque” builds up in the major blood vessels in the neck (“carotid arteries”), blood clots can form, break off, and travel to the brain, causing a stroke. In this clinical trial we plan to test a new drug for its ability to shrink carotid artery plaques, which might help to cut the risk of strokes.
The drug is called “Evolocumab”, and is already used in people who have high cholesterol, for whom it reduced the risk of heart attacks. In this study we are interested in people who already have a lot of plaque in their carotid arteries (“carotid stenosis”), with the aim iof seeing whether Evolocumab reduces the amount of cholesterol in the plaque. Specifically, we plan to recruit people who have significant carotid stenosis, but not so much that they would usually be offered an operation to remove it.
The study will take place at the Imperial College Healthcare NHS Trust hospitals in London. Patients attending our clinics who are found to have carotid stenosis (by normal tests done by their doctors) may be offered the chance to take part. The study involves self-administering the drug – or an inactive placebo – using a pen-like device which injects under the skin via a tiny needle. The injections are every two weeks and continue for a year; the study continues for a further year after that, without any drug, to see what happens after the drug is stopped. To avoid skewing the results, participants will not know whether they are receiving the active drug or inactive placebo.
To look at the effect of the drug on the carotid arteries, participants will have four MRI scans, each of which will last up to an hour. There will also be face-to-face interviews with the research nurse, telephone interviews, and blood tests.
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/0138
Date of REC Opinion
6 Mar 2019
REC opinion
Further Information Favourable Opinion