Cardiovascular DiseasesPhase 2NITRATE-OCTNCT02529189
Investigating the Effects of Dietary Nitrate on Vascular Function, Platelet Reactivity and Restenosis in Stable Angina
A Phase 2 study testing Beetroot Juice in people with Cardiovascular Diseases, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
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. Whilst this procedure has revolutionised treatment the incidence of secondary events remains a concern. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Beetroot Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Nov 2015to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable angina diagnosed by a cardiologist on optimal medical therapy undergoing angioplasty to treat residual symptoms.
- Aged 18-85
- Patients able and willing to give their written informed consent.
- Patients undergoing successful PCI procedure.
Who cannot join
- Unstable ischaemic heart disease, with an episode of chest pain in less than 24 hours.
- Patients who have had previous coronary artery bypass surgery (CABG), if they are undergoing angioplasty within a non-native vessel.
- Patients undergoing angioplasty with a bio-absorbable stent.
- Current diagnosis of or treatment for malignancy, other than non-melanoma skin cancer.
- Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
- Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication.
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- Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures).
- Severe acute infection, or significant trauma (burns, fractures).
- Pregnancy. This will be tested by urine human chorionic gonadotropin (hCG) measurement
- History of alcohol or drug abuse within the past 6 months.
- A history of heart failure New York Heart Association (NYHA) class 3-4 or severe left ventricular dysfunction (left ventricular ejection fraction of <30%) regardless of symptom status.
- Systemic autoimmune disease such as rheumatoid arthritis, connective tissue disease, or other conditions known to be associated with chronic inflammation such as inflammatory bowel disease.
- Patients who have donated > 500mls blood within 56 days prior to study medication administration.
- Anaemia with Hb <10g/dl, or any other known blood disorder or significant illness that may affect platelet function, and coagulation.
- A history of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody or other chronic hepatic disorder) or HIV.
- Abnormal liver function due to acute or chronic liver conditions 3 x upper limit of normal at screening.
- Renal impairment with creatinine clearance (eGFR) of 35ml/min at screening.
- If patients are on mouthwash, they must be willing to stop using this at least 1 week before the start of the study and throughout the duration that they are involved in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
William Harvey Research Institute, Barts and The London School of Medicine
London, EC1M 6BQ
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study Investigating the Effects of Dietary Nitrate on Vascular Function, Platelet Reactivity and Restenosis in Stable Angina
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. Whilst this procedure has revolutionised treatment the incidence of secondary events remains a concern. These repeat events are due in part to continued enhanced platelet reactivity, endothelial dysfunction and a phenomenon called 'restenosis' i.e. the stent becomes blocked ultimately requiring another expensive and risky procedure. In this study it will be determined whether a once daily inorganic nitrate administration might favourably modulate platelet reactivity and endothelial function leading to a decrease in restenosis.
Read the detailed description
To address the aims a proof-of-concept study will be conducted to ascertain whether a dietary nitrate approach might prove useful adjunctive therapy improving vascular function in patients with stable angina post elective angioplasty.
Design: A prospective randomised, single-centre, double-blind, placebo-controlled trial
Setting: Patients with stable angina and single/multiple coronary artery stenosis undergoing elective percutaneous coronary intervention (PCI) who are haemodynamically stable (systolic BP>100 mmHg). These patients will be recruited at The Barts Health Heart Centre, based at St. Bartholomew's Hospital. This is one of the biggest centres in the United Kingdom, serving a population of almost two million people from The City of London and The North East up to the M25 and is a 24/7 centre performing approximately 2000 non-primary angioplasties a year.
The study will take place in the Clinical Trials Unit, William Harvey Heart Centre.
Target population: A total of 300 patients (male and female, age 18-85) with stable angina as per requirements indicated above. Follow-up will take place in the Clinical Trials Unit, William Harvey Research Institute.
Treatment: Patients will be randomised (using an on line randomisation database) to receive 70 ml of a beetroot juice concentrate containing 4-5 mmol nitrate or nitrate-deplete placebo juice concentrate. This intervention will be taken by the patient daily from one day prior to re-establishment of flow with PCI and stent implantation.
Analysis: We will analyse the results based on an intention to treat analysis. We will also carry out further per protocol analyses and a subgroup analysis on patients who are on organic nitrates as part of their routine therapy and a comparison of DES (drug-eluting stents) versus BMS (bare-metal stents).
- Conditions
- Cardiovascular Diseases
- Being tested
- Beetroot Juice
- Keywords
- Stable Angina, Angioplasty, Optical Coherence Tomography, Nitrate
- Medical subject headings
- Cardiovascular Diseases, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot JuiceDietary supplement
70 ml of beetroot juice containing ~5 mmol of inorganic nitrate
Beetroot JuiceDietary supplement
70 ml of beetroot juice which is nitrate-depleted
| Study group | Role | What they receive |
|---|---|---|
| Nitrate-rich beetroot juice | Active comparator | 70 ml of a beetroot juice concentrate containing ~5 mmol nitrate Receives: Dietary Supplement: Beetroot Juice |
| Nitrate-deplete beetroot juice | Placebo comparator | 70 ml of a beetroot juice concentrate that is nitrate-depleted Receives: Dietary Supplement: Beetroot Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between groups in In-stent late loss, where late loss is defined as the difference between the minimum luminal diameter (MLD).
Measured: 6 months +/- 1 month post intervention
Secondary outcomes (12)
Difference from baseline within the group and between groups in endothelial function assessed by flow-mediated dilatation of the brachial artery at 6 months compared to pre-procedure assessment.
Measured: 6 months and 12 months post intervention
Difference from baseline within the group and between groups in target vessel revascularisation (TVR).
Measured: 6 months post intervention
Difference from baseline within the group and between groups in restenosis rate (diameter >50%).
Measured: 6 months post intervention
Difference from baseline within the group and between groups in in-segment late loss.
Measured: 6 months post intervention
Difference from baseline between groups in major adverse cardiac events (i.e. Myocardial Infarction, death, Cerebrovascular Accident, Target Vascular Revascularisation).
Measured: 6 months, 12 months and 24 months post intervention
Difference from baseline within the group and between groups in inflammatory markers.
Measured: 6 months and 12 months post intervention
Difference from baseline within the group and between groups in plasma and erythrocyte nitrite reductase.
Measured: 6 months and 12 months post intervention
Difference from baseline within the group and between groups in changes in plasma xanthine oxidase activity.
Measured: 6 months and 12 months post intervention
Difference from baseline within the group and between groups high-sensitivity C-reactive protein (hsCRP).
Measured: 6 months and 12 months post intervention
Difference from baseline within the group and between groups in Interleukin-6 (IL-6).
Measured: 6 months and 12 months post intervention
Difference from baseline within the group and between groups in platelet activation (P-Selectin and platelet-monocyte aggregates).
Measured: 6 months and 12 months post intervention
Difference from baseline within the group and between groups in platelet aggregation ex vivo (ADP, collagen, arachidonic acid).
Measured: 6 months and 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study start2 Nov 2015
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- Amrita Ahluwalia, PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529189
- Sponsor's protocol ID
- 15/LO/0555
- Acronym
- NITRATE-OCT
- Status last verified
- Jun 2025
- First submitted
- 7 Aug 2015
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kapil V, Khambata RS, Robertson A, Caulfield MJ, Ahluwalia A. Dietary nitrate provides sustained blood pressure lowering in hypertensive patients: a randomized, phase 2, double-blind, placebo-controlled study. Hypertension. 2015 Feb;65(2):320-7. doi: 10.1161/HYPERTENSIONAHA.114.04675. Epub 2014 Nov 24.
PubMed 25421976Ghosh SM, Kapil V, Fuentes-Calvo I, Bubb KJ, Pearl V, Milsom AB, Khambata R, Maleki-Toyserkani S, Yousuf M, Benjamin N, Webb AJ, Caulfield MJ, Hobbs AJ, Ahluwalia A. Enhanced vasodilator activity of nitrite in hypertension: critical role for erythrocytic xanthine oxidoreductase and translational potential. Hypertension. 2013 May;61(5):1091-102. doi: 10.1161/HYPERTENSIONAHA.111.00933. Epub 2013 Apr 15.
PubMed 23589565Rathod KS, Mathur A, Shabbir A, Khambata RS, Lau C, Beirne AM, Chhetri I, Ono M, Belgaid DR, Massimo G, Ramasamy A, Tufaro V, Jain AK, Poulter N, Falaschetti E, Jones DA, Garcia-Garcia HM, Bourantas C, Learoyd A, Warren HR, Ahluwalia A. The NITRATE-OCT study-inorganic nitrate reduces in-stent restenosis in patients with stable coronary artery disease: a double-blind, randomised controlled trial. EClinicalMedicine. 2024 Oct 18;77:102885. doi: 10.1016/j.eclinm.2024.102885. eCollection 2024 Nov.
PubMed 39469537Rathod KS, Jones DA, Van-Eijl TJ, Tsang H, Warren H, Hamshere SM, Kapil V, Jain AK, Deaner A, Poulter N, Caulfield MJ, Mathur A, Ahluwalia A. 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. BMJ Open. 2016 Dec 20;6(12):e012728. doi: 10.1136/bmjopen-2016-012728.
PubMed 27998900
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study Investigating the Effects of Dietary Nitrate on Vascular Function, Platelet Reactivity and Restenosis in Stable Angina
- ClinicalTrials.gov ID
- NCT02529189
- Acronym / sponsor ID
- NITRATE-OCT / 15/LO/0555
- Conditions
- Cardiovascular Diseases
- Keywords
- Stable Angina, Angioplasty, Optical Coherence Tomography, Nitrate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Whilst this procedure has revolutionised treatment the incidence of secondary events remains a concern. These repeat events are due in part to continued enhanced platelet reactivity, endothelial dysfunction and a phenomenon called 'restenosis' i.e. the stent becomes blocked ultimately requiring another expensive and risky procedure. In this study it will be determined whether a once daily inorganic nitrate administration might favourably modulate platelet reactivity and endothelial function leading to a decrease in restenosis.
Detailed description
To address the aims a proof-of-concept study will be conducted to ascertain whether a dietary nitrate approach might prove useful adjunctive therapy improving vascular function in patients with stable angina post elective angioplasty.
Design: A prospective randomised, single-centre, double-blind, placebo-controlled trial
Setting: Patients with stable angina and single/multiple coronary artery stenosis undergoing elective percutaneous coronary intervention (PCI) who are haemodynamically stable (systolic BP>100 mmHg). These patients will be recruited at The Barts Health Heart Centre, based at St. Bartholomew's Hospital. This is one of the biggest centres in the United Kingdom, serving a population of almost two million people from The City of London and The North East up to the M25 and is a 24/7 centre performing approximately 2000 non-primary angioplasties a year.
The study will take place in the Clinical Trials Unit, William Harvey Heart Centre.
Target population: A total of 300 patients (male and female, age 18-85) with stable angina as per requirements indicated above. Follow-up will take place in the Clinical Trials Unit, William Harvey Research Institute.
Treatment: Patients will be randomised (using an on line randomisation database) to receive 70 ml of a beetroot juice concentrate containing 4-5 mmol nitrate or nitrate-deplete placebo juice concentrate. This intervention will be taken by the patient daily from one day prior to re-establishment of flow with PCI and stent implantation.
Analysis: We will analyse the results based on an intention to treat analysis. We will also carry out further per protocol analyses and a subgroup analysis on patients who are on organic nitrates as part of their routine therapy and a comparison of DES (drug-eluting stents) versus BMS (bare-metal stents).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate-rich beetroot juice | Active comparator | Dietary Supplement: Beetroot Juice70 ml of a beetroot juice concentrate containing ~5 mmol nitrate |
| Nitrate-deplete beetroot juice | Placebo comparator | Dietary Supplement: Beetroot Juice70 ml of a beetroot juice concentrate that is nitrate-depleted |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with stable angina diagnosed by a cardiologist on optimal medical therapy undergoing angioplasty to treat residual symptoms.
- Aged 18-85
- Patients able and willing to give their written informed consent.
- Patients undergoing successful PCI procedure.
Key exclusion criteria (18 listed)
- Unstable ischaemic heart disease, with an episode of chest pain in less than 24 hours.
- Patients who have had previous coronary artery bypass surgery (CABG), if they are undergoing angioplasty within a non-native vessel.
- Patients undergoing angioplasty with a bio-absorbable stent.
- Current diagnosis of or treatment for malignancy, other than non-melanoma skin cancer.
- Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot Juice70 ml of beetroot juice containing ~5 mmol of inorganic nitrate | Dietary supplement | Nitrate-rich beetroot juice |
| Beetroot Juice70 ml of beetroot juice which is nitrate-depleted | Dietary supplement | Nitrate-deplete beetroot juice |
Primary outcome
Difference between groups in In-stent late loss, where late loss is defined as the difference between the minimum luminal diameter (MLD).
Time frame: 6 months +/- 1 month post intervention
12 secondary outcomes
Difference from baseline within the group and between groups in endothelial function assessed by flow-mediated dilatation of the brachial artery at 6 months compared to pre-procedure assessment.
Time frame: 6 months and 12 months post intervention
Difference from baseline within the group and between groups in target vessel revascularisation (TVR).
Time frame: 6 months post intervention
Difference from baseline within the group and between groups in restenosis rate (diameter >50%).
Time frame: 6 months post intervention
Difference from baseline within the group and between groups in in-segment late loss.
Time frame: 6 months post intervention
Difference from baseline between groups in major adverse cardiac events (i.e. Myocardial Infarction, death, Cerebrovascular Accident, Target Vascular Revascularisation).
Time frame: 6 months, 12 months and 24 months post intervention
Difference from baseline within the group and between groups in inflammatory markers.
Time frame: 6 months and 12 months post intervention
Difference from baseline within the group and between groups in plasma and erythrocyte nitrite reductase.
Time frame: 6 months and 12 months post intervention
Difference from baseline within the group and between groups in changes in plasma xanthine oxidase activity.
Time frame: 6 months and 12 months post intervention
Difference from baseline within the group and between groups high-sensitivity C-reactive protein (hsCRP).
Time frame: 6 months and 12 months post intervention
Difference from baseline within the group and between groups in Interleukin-6 (IL-6).
Time frame: 6 months and 12 months post intervention
Difference from baseline within the group and between groups in platelet activation (P-Selectin and platelet-monocyte aggregates).
Time frame: 6 months and 12 months post intervention
Difference from baseline within the group and between groups in platelet aggregation ex vivo (ADP, collagen, arachidonic acid).
Time frame: 6 months and 12 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Background: PubMed 25421976Kapil V, Khambata RS, Robertson A, Caulfield MJ, Ahluwalia A. Dietary nitrate provides sustained blood pressure lowering in hypertensive patients: a randomized, phase 2, double-blind, placebo-controlled study. Hypertension. 2015 Feb;65(2):320-7. doi: 10.1161/HYPERTENSIONAHA.114.04675. Epub 2014 Nov 24.
- Background: PubMed 23589565Ghosh SM, Kapil V, Fuentes-Calvo I, Bubb KJ, Pearl V, Milsom AB, Khambata R, Maleki-Toyserkani S, Yousuf M, Benjamin N, Webb AJ, Caulfield MJ, Hobbs AJ, Ahluwalia A. Enhanced vasodilator activity of nitrite in hypertension: critical role for erythrocytic xanthine oxidoreductase and translational potential. Hypertension. 2013 May;61(5):1091-102. doi: 10.1161/HYPERTENSIONAHA.111.00933. Epub 2013 Apr 15.
- Derived from this study: PubMed 39469537Rathod KS, Mathur A, Shabbir A, Khambata RS, Lau C, Beirne AM, Chhetri I, Ono M, Belgaid DR, Massimo G, Ramasamy A, Tufaro V, Jain AK, Poulter N, Falaschetti E, Jones DA, Garcia-Garcia HM, Bourantas C, Learoyd A, Warren HR, Ahluwalia A. The NITRATE-OCT study-inorganic nitrate reduces in-stent restenosis in patients with stable coronary artery disease: a double-blind, randomised controlled trial. EClinicalMedicine. 2024 Oct 18;77:102885. doi: 10.1016/j.eclinm.2024.102885. eCollection 2024 Nov.
- Derived from this study: PubMed 27998900Rathod KS, Jones DA, Van-Eijl TJ, Tsang H, Warren H, Hamshere SM, Kapil V, Jain AK, Deaner A, Poulter N, Caulfield MJ, Mathur A, Ahluwalia A. 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. BMJ Open. 2016 Dec 20;6(12):e012728. doi: 10.1136/bmjopen-2016-012728.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amrita Ahluwalia, PhD principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beetroot Juice in people with Cardiovascular Diseases, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between groups in In-stent late loss, where late loss is defined as the difference between the minimum luminal diameter (MLD). (time frame: 6 months +/- 1 month post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529189, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.