Pycnogenol and Endothelial Function in Coronary Artery Disease

University of Zurich (UZH)

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Drug: Pycnogenol

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00641758

Pycno2007-003

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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