CXCR2 inhibition and coronary heart disease / CICADA
Research type
Research Study
Full title
CXCR2 inhibition: a novel approach to treating coronary heart disease
IRAS ID
192947
Contact name
Albert Ferro
Contact email
Sponsor organisation
King's College London
Eudract number
2016-000775-24
ISRCTN Number
ISRCTN48328178
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
Atherosclerosis is an inflammatory disease of blood vessels, which gives rise to fatty deposits ('atheromatous plaques') and narrowing of those vessels. It is the commonest cause of death and disability in the Western world, and its thrombotic complications - predominantly myocardial infarction ('heart attack') and stroke - are initiated by plaque erosion and rupture, a process in which white blood cells (in particular neutrophils) play a prominent role. In this study, we will determine whether inhibition of neutrophil migration into plaques, using the novel drug AZD5069 (which inhibits a molecule called CXCR2, which is central to normal neutrophil function), will improve the structure and function of coronary arteries in patients with coronary heart disease who are undergoing interventional treatment for atherosclerosis in their coronary arteries involving balloon dilatation of narrowed areas together with placement of a stent (so-called percutaneous coronary intervention, or PCI). We will randomise patients with coronary heart disease undergoing PCI to receive either AZD5069 or placebo, on top of usual therapy, for a period of 6 months. The primary outcome measure will be the effect of CXCR2 inhibition on coronary vascular function, as measured by coronary flow reserve (a measure of the coronary arteries to dilate, assessed by PET scanning, and in a subset with invasive coronary flow measurements). Secondary outcome measures will be plaque re-narrowing ('restenosis', assessed by intravascular ultrasound or IVUS) and internal structure (again by IVUS), as well as change in small blood vessel function (measured using a special wire in the coronary arteries called a ComboWire). These measures will indicate whether CXCR2 inhibition is likely to lead to an improvement in outcome in such patients in the longer term.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0478
Date of REC Opinion
29 Sep 2016
REC opinion
Further Information Favourable Opinion