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Clinical Trials/ISRCTN17373946
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

Queen Mary University of London0 sites246 target enrollmentNovember 5, 2015

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)

Registry
who.int
Start Date
November 5, 2015
End Date
April 2, 2018
Last Updated
4 years ago
Study Type
Interventional
Sex
All

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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