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Randomised, double-blind, placebo-controlled study investigating the effects of inorganic nitrate on vascular function, platelet reactivity and restenosis in stable angina: protocol of the NITRATE-OCT study.

ABSTRACT: 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 double-blind, 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 nitrate-deplete 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. ETHICS AND DISSEMINATION:The study was approved by the Local Ethics Committee (15/LO/0555). Trial results will be published according to the CONSORT statement and will be presented at conferences and reported in peer-reviewed journals. TRIAL REGISTRATION NUMBERS:NCT02529189 and ISRCTN17373946, Pre-results.

SUBMITTER: Rathod KS

PROVIDER: S-EPMC5223652 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Randomised, double-blind, placebo-controlled study investigating the effects of inorganic nitrate on vascular function, platelet reactivity and restenosis in stable angina: protocol of the NITRATE-OCT study.

Rathod Krishnaraj S KS Jones Daniel A DA Van-Eijl T J A TJ Tsang Hilda H Warren Helen H Hamshere Stephen M SM Kapil Vikas V Jain Ajay K AK Deaner Andrew A Poulter Neil N Caulfield Mark J MJ Mathur Anthony A Ahluwalia Amrita A

BMJ open 20161220 12

<h4>Introduction</h4>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 inv ...[more]

PMID: 27998900

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Project description:In this double-blind randomized placebo-controlled crossover trial, we investigated whether oral sodium nitrate, when added to existing background medication, reduces exertional ischemia in patients with angina.Seventy patients with stable angina, positive electrocardiogram treadmill test, and either angiographic or functional test evidence of significant ischemic heart disease were randomized to receive oral treatment with either placebo or sodium nitrate (600 mg; 7 mmol) for 7 to 10 days, followed by a 2-week washout period before crossing over to the other treatment (n=34 placebo-nitrate, n=36 nitrate-placebo). At baseline and at the end of each treatment, patients underwent modified Bruce electrocardiogram treadmill test, modified Seattle Questionnaire, and subgroups were investigated with dobutamine stress, echocardiogram, and blood tests. The primary outcome was time to 1 mm ST depression on electrocardiogram treadmill test. Compared with placebo, inorganic nitrate treatment tended to increase the primary outcome exercise time to 1 mm ST segment depression (645.6 [603.1, 688.0] seconds versus 661.2 [6183, 704.0] seconds, P=0.10) and significantly increased total exercise time (744.4 [702.4, 786.4] seconds versus 760.9 [719.5, 802.2] seconds, P=0.04; mean [95% confidence interval]). Nitrate treatment robustly increased plasma nitrate (18.3 [15.2, 21.5] versus 297.6 [218.4, 376.8] ?mol/L, P<0.0001) and almost doubled circulating nitrite concentrations (346 [285, 405] versus 552 [398, 706] nmol/L, P=0.003; placebo versus nitrate treatment). Other secondary outcomes were not significantly altered by the intervention. Patients on antacid medication appeared to benefit less from nitrate supplementation.Sodium nitrate treatment may confer a modest exercise capacity benefit in patients with chronic angina who are taking other background medication.URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02078921. EudraCT number: 2012-000196-17.

Project description:Background Canadian Cardiovascular Society (CCS) angina severity classification is associated with mortality, myocardial infarction, and coronary revascularization in clinical trial and registry data. The objective of this study was to determine associations between CCS class and all-cause mortality and healthcare utilization, using natural language processing to extract CCS classifications from clinical notes. Methods and Results In this retrospective cohort study of veterans in the United States with stable angina from January 1, 2006, to December 31, 2013, natural language processing extracted CCS classifications. Veterans with a prior diagnosis of coronary artery disease were excluded. Outcomes included all-cause mortality (primary), all-cause and cardiovascular-specific hospitalizations, coronary revascularization, and 1-year healthcare costs. Of 299 577 veterans identified, 14 216 (4.7%) had ≥1 CCS classification extracted by natural language processing. The mean age was 66.6±9.8 years, 99% of participants were male, and 81% were white. During a median follow-up of 3.4 years, all-cause mortality rates were 4.58, 4.60, 6.22, and 6.83 per 100 person-years for CCS classes I, II, III, and IV, respectively. Multivariable adjusted hazard ratios for all-cause mortality comparing CCS II, III, and IV with those in class I were 1.05 (95% CI, 0.95-1.15), 1.33 (95% CI, 1.20-1.47), and 1.48 (95% CI, 1.25-1.76), respectively. The multivariable hazard ratio comparing CCS IV with CCS I was 1.20 (95% CI, 1.09-1.33) for all-cause hospitalization, 1.25 (95% CI, 0.96-1.64) for acute coronary syndrome hospitalizations, 1.00 (95% CI, 0.80-1.26) for heart failure hospitalizations, 1.05 (95% CI, 0.88-1.25) for atrial fibrillation hospitalizations, 1.92 (95% CI, 1.40-2.64) for percutaneous coronary intervention, and 2.51 (95% CI, 1.99-3.16) for coronary artery bypass grafting surgery. Conclusions Natural language processing-extracted CCS classification was positively associated with all-cause mortality and healthcare utilization, demonstrating the prognostic importance of anginal symptom assessment and documentation.

Dataset Information

Randomised, double-blind, placebo-controlled study investigating the effects of inorganic nitrate on vascular function, platelet reactivity and restenosis in stable angina: protocol of the NITRATE-OCT study.

Publications

Randomised, double-blind, placebo-controlled study investigating the effects of inorganic nitrate on vascular function, platelet reactivity and restenosis in stable angina: protocol of the NITRATE-OCT study.

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