A Double-blind, Randomized, Placebo-controlled, Cross - Over Design, Single Center Study to Evaluate the Effects of Treatment With Pycnogenol® on Endothelial Function in Subjects With Stable Coronary Artery Disease (Pycno2007-003)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to evaluate the effects of treatment with Pycnogenol® on endothelial function in subjects with stable coronary artery disease.
研究概览
简要总结
Pycnogenol® is a proprietary bark extract of the French maritime pine tree (Pinus pinaster ssp. atlantica). Pycnogenol® has prevented pathologic symptoms such as chronic inflammation and increased platelet aggregation, a risk factor for cardiovascular diseases. The endothelium is increasingly recognized not only a target (with vascular remodelling occurring in response to an injury and resulting in atherosclerosis), but also a mediator in the pathogenesis of atherosclerosis. Indeed, endothelial cells play an important regulatory role in the cardiovascular system by the expression of numerous molecules and release of mediators such as nitric oxide (NO), superoxide and endothelin-1 (ET-1). Data from animal studies, as well as human studies indicate that Pycnogenol may improve endothelial function, which is a powerful surrogate for clinical prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of coronary artery disease (documented by coronary angiogram, nuclear imaging, positive stress test)
- •Stable cardiovascular medication for at least 1 month
- •Age ≥ 18 years of age at time of signing the informed consent
- •Informed consent for participation in the study
排除标准
- •Myocardial infarction, unstable angina, stroke (within 3 months before randomization)
- •Thoracic or cardiac surgery and/or coronary intervention/revascularisation procedure (within 3 months before randomization)
- •Uncontrolled symptomatic congestive heart failure (NHYA> II) in the last 4 weeks prior to study
- •Renal insufficiency (Creatinine Clearance < 50ml/min)
- •Ventricular tachyarrhythmias
- •Poorly controlled hypertension, defined as resting blood pressure ≥ 160/100 mmHg
- •Symptomatic hypotension
- •Obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism and adrenal insufficiency
- •Severe uncorrected valvular disease or left ventricular outflow obstruction, which, in the opinion of the investigator, requires surgery
- •Long acting nitrates
- •Oral or intravenous steroids therapy
- •Insulin - dependent diabetes mellitus
- •Recipient of any major organ transplant (eg, lung, liver, heart) or renal replacement therapy
- •Malignancy (unless healed or remission > 5 years)
- •Anaemia (Hb< 10g/dl)
- •Known to be human immunodeficiency virus (HIV) positive or active virus - hepatitis
- •Alanine transaminase (ALT) or aspartate transaminase (AST) > 3 times the upper limit of the normal range
- •Known hypersensitivity to Pycnogenol®
- •Alcohol, nicotine abuse or illicit drug abuse
- •Pregnancy or breast-feeding, women with child - bearing potential without adequate contraception
- •Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
- •Participation in another study within the last month
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Pycnogenol
干预措施: Pycnogenol (Drug)
结局指标
主要结局
The primary objective of this study is to evaluate the effects of treatment with Pycnogenol® on endothelial function in subjects with stable coronary artery disease.
时间窗: 8 weeks
次要结局
- Secondary objectives are to evaluate the effect of 8 weeks treatment with Pycnogenol® on inflammation markers, oxidative stress parameters, endothelial progenitor cells, platelet function, 24 hours blood pressure and baroreflex function.(8 weeks)