Pycnogenol and Endothelial Function in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641758
• Other study ID #: Pycno2007-003
• Status: Completed
• Phase: N/A
• First received: March 17, 2008
• Last updated: February 9, 2010
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: February 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Pycnogenol
Pycnogenol 100mg twice daily
• Placebo
Placebo 100mg twice daily

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		8 weeks	No
Secondary	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	No