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CXCR2 Inhibition - a novel approach to treating CoronAry heart DiseAse (CICADA): study protocol for a randomised controlled trial.
- Source :
-
Trials [Trials] 2017 Oct 11; Vol. 18 (1), pp. 473. Date of Electronic Publication: 2017 Oct 11. - Publication Year :
- 2017
-
Abstract
- Background: There is emerging evidence of the central role of neutrophils in both atherosclerotic plaque formation and rupture. Patients with lower neutrophil counts following acute coronary syndromes tend to have a greater coronary flow reserve, which is a strong predictor of long-term cardiovascular health. But so far, no data are available regarding the impact of neutrophil inhibition on cardiovascular clinical or surrogate endpoints. Therefore, the aim of this study is to investigate the effects of AZD5069, a cysteine-X-cysteine chemokine receptor 2 (CXCR2) inhibitor, on coronary flow reserve and coronary structure and function in patients with coronary artery disease.<br />Methods/design: Ninety subjects with coronary artery disease undergoing percutaneous coronary intervention will be included in this investigator-driven, randomised, placebo-controlled, double-blind, phase IIa, single-centre study. Participants will be randomised to receive either AZD5069 (40 mg) administered orally twice daily or placebo for 24 weeks. Change in coronary flow reserve as determined by <superscript>13</superscript> N-ammonia positron emission tomography-computed tomography will be the primary outcome. Change in the inflammatory component of coronary plaque structure and the backward expansion wave, an invasive coronary physiological measure of diastolic function, will be assessed as secondary outcomes.<br />Discussion: Cardiovascular surrogate parameters, such as coronary flow reserve, may provide insights into the potential mechanisms of the cardiovascular effects of CXCR2 inhibitors. Currently, ongoing trials do not specifically focus on neutrophil function as a target of intervention, and we therefore believe that our study will contribute to a better understanding of the role of neutrophil-mediated inflammation in coronary artery disease.<br />Trial Registration: EudraCT, 2016-000775-24 . Registered on 22 July 2016. International Standard Randomised Controlled Trial Number, ISRCTN48328178 . Registered on 25 February 2016.
- Subjects :
- Anti-Inflammatory Agents adverse effects
Clinical Protocols
Coronary Artery Disease blood
Coronary Artery Disease diagnostic imaging
Coronary Artery Disease physiopathology
Coronary Circulation drug effects
Coronary Vessels diagnostic imaging
Coronary Vessels physiopathology
Double-Blind Method
Female
Humans
London
Male
Myocardial Perfusion Imaging methods
Neutrophils metabolism
Percutaneous Coronary Intervention adverse effects
Positron Emission Tomography Computed Tomography
Prospective Studies
Pyrimidines adverse effects
Receptors, Interleukin-8B blood
Research Design
Sulfonamides adverse effects
Time Factors
Treatment Outcome
Anti-Inflammatory Agents therapeutic use
Coronary Artery Disease therapy
Coronary Vessels drug effects
Neutrophils drug effects
Pyrimidines therapeutic use
Receptors, Interleukin-8B antagonists & inhibitors
Sulfonamides therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 18
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 29020983
- Full Text :
- https://doi.org/10.1186/s13063-017-2210-2