Pycnogenol and Endothelial Function in Coronary Artery Disease

Launched by UNIVERSITY OF ZURICH · Mar 17, 2008

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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