ISRCTN17373946
Completed
Phase 2
A randomised, double-blind, placebo-controlled study investigating the effects of dietary nitrate on vascular function, platelet reactivity and restenosis in stable angina
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Topic: Cardiovascular disease
- Sponsor
- Queen Mary University of London
- Enrollment
- 246
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27998900 (added 10/04/2019)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged between 18 and 85
- •2\. Able and willing to provide informed consent
- •3\. Patients undergoing successful PCI procedure
- •4\. Patients with stable angina diagnosed by a cardiologist on optimal medical therapy, undergoing an angioplasty to treat residual symptoms
Exclusion Criteria
- •1\. Unstable ischaemic heart disease, with an episode of chest pain less than 24 hours
- •2\. In patients who have had previous coronary artery bypass surgery (CABG), if they are undergoing angioplasty within a non\-native vessel
- •3\. Patients undergoing angioplasty with a bio\-absorbable stent
- •4\. Current diagnosis of or treatment for malignancy, other than nonmelanoma skin cancer
- •5\. Current lifethreatening condition other than vascular disease that may prevent a subject completing the study
- •6\. 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
- •7\. 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)
- •8\. Severe acute infection, or significant trauma (burns, fractures)
- •9\. Pregnancy (tested by urine HcG measurement)
- •10\. History of alcohol or drug abuse within the past 6 months
Outcomes
Primary Outcomes
Not specified
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