ISRCTN17373946已完成2 期
A randomised, double-blind, placebo-controlled study investigating the effects of dietary nitrate on vascular function, platelet reactivity and restenosis in stable angina
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 246
研究概览
简要总结
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27998900 (added 10/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •11. A history of heart failure NYHA class 34 or severe LV dysfunction LVEF<30% regardless of symptom status
- •12. 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
- •13. Patients who have donated > 500mls blood within 56 days prior to study medication administration
- •14. Anaemia with Hb <10g/dl, or any other known blood disorder or significant illness that may affect platelet function, and coagulation
- •15. A history of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody or other chronic hepatic disorder) or HIV
- •16. Abnormal liver function due to acute or chronic liver conditions 3 x upper limit of normal at screening
- •17. Renal impairment with creatinine clearance (eGFR) of 30ml/min at screening
- •18. 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 within the study
研究者
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