Coronary heart disease Circulatory System
Conditions
Interventions
The trial will be a randomised double-blind placebo-controlled parallel group study. Eligible patients (n=90) undergoing percutaneous coronary intervention (PCI) either for stable coronary disease or
Sponsors
King's College London
Guy's & St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women = 18 years of age 2. Angiographically proven coronary heart disease undergoing native-vessel PCI for non-ST-elevation myocardial infarction or unstable or stable coronary disease 3. Absolute blood neutrophil count at the time of PCI as well as 4 weeks after PCI of >4.0 x 109/L 4. Otherwise receiving standard of care for ischaemic heart disease (including appropriate anti-platelet therapy, statin, antihypertensive as clinically indicated)
Exclusion criteria
Exclusion criteria: 1. At any time after initial screening (ie at the time of PCI + IVUS), requirement or anticipated requirement, by clinical care guideline or in the opinion of the treating physician, for a new medication which may affect trial primary and / or secondary endpoints (ie specifically new lipid lowering therapy, anti-hypertensive therapy, or immunomodulatory therapy). Note that dose titration of chronic therapy initiated prior to PCI is permissible during the trial. 2. History of inability or, in the opinion of the investigator, anticipated inability to tolerate adenosine-based pharmacologic stress testing (e.g. active pulmonary broncho-constrictive disorder, second or third degree AV block without a cardiac pacemaker, resting systolic blood pressure 450 ms for males and 470 ms for females 4-weeks after PCI 18. Current evidence of drug abuse or significant history of drug abuse, as judged by the investigator.; 19. Current evidence of alcohol abuse or a significant history of alcohol abuse, as judged by the investigator 20. Pregnancy or breast feeding during the study 21. Contraindication to any of the study tre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coronary vascular function, measured by change in coronary flow reserve (a measure of the coronary arteries to dilate, assessed by PET scanning, and, in a subset, invasive coronary flow measurements) from baseline to 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in plaque composition, measured using intravascular ultrasound (IVUS) at baseline and at 24 weeks 2. Degree of in-stent restenosis, measured using intravascular ultrasound at baseline and at 24 weeks 3. Change in microvascular resistance, done by by CombiWire assessment (involving insertion of a specialised flow-measurement wire into the coronary arteries) at baseline and at 6 months (on a subgroup of patients) | — |
Countries
England, United Kingdom
Outcome results
None listed