Introduction: The mainstay treatment for reducing the
symptoms of angina and long-term risk of heart
attacks in patients with heart disease is stent
implantation in the diseased coronary artery. While this
procedure has revolutionised treatment, the incidence
of secondary events remains a concern. These repeat
events are thought to be due, in part, to continued
enhanced platelet reactivity, endothelial dysfunction
and ultimately restenosis of the stented artery. In this
study, we will investigate whether a once a day
inorganic nitrate administration might favourably
modulate platelet reactivity and endothelial function
leading to a decrease in restenosis.
Methods and design: NITRATE-OCT is a doubleblind,
randomised, single-centre, placebo-controlled
phase II trial that will enrol 246 patients with stable
angina due to have elective percutaneous coronary
intervention procedure with stent implantation. Patients
will be randomised to receive 6 months of a once a
day dose of either nitrate-rich beetroot juice or nitratedeplete
beetroot juice ( placebo) starting up to 1 week
before their procedure. The primary outcome is
reduction of in-stent late loss assessed by quantitative
coronary angiography and optical coherence
tomography at 6 months. The study is powered to
detect a 0.22±0.55 mm reduction in late loss in the
treatment group compared with the placebo group.
Secondary end points include change from baseline
assessment of endothelial function measured using
flow-mediated dilation at 6 months, target vessel
revascularisation (TVR), restenosis rate (diameter>50%)
and in-segment late loss at 6 months, markers of
inflammation and platelet reactivity and major adverse
cardiac events (ie, myocardial infarction, death,
cerebrovascular accident, TVR) at 12 and 24 months.