Pycnogenol and Endothelial Function in Coronary Artery Disease - Full Text View

Sponsored by:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00641758

Purpose

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.

Condition	Intervention
Coronary Artery Disease	Drug: Pycnogenol Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Pycnogenol

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:

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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Placebo Placebo 100mg twice daily
Pycnogenol: Active Comparator	Drug: Pycnogenol Pycnogenol 100mg twice daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641758

Contacts

Contact: Georg Noll, MD

+41 44 255 21 82

georg.noll@usz.ch

Locations

Switzerland
University of Zurich	Recruiting
Zurich, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator:

Georg Noll, MD

University of Zurich

More Information

No publications provided

Responsible Party:	University of Zurich ( Prof. Dr. med. Georg Noll )
Study ID Numbers:	Pycno2007-003
Study First Received:	March 17, 2008
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00641758 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by University of Zurich:

Coronary Artery Disease
endothelial dysfunction
Nitric oxide

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Immunologic Factors
Pycnogenols
Myocardial Ischemia
Vascular Diseases
Adjuvants, Immunologic

Ischemia
Arteriosclerosis
Coronary Disease
Nitric Oxide
Platelet Aggregation Inhibitors
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Immunologic Factors
Pycnogenols
Myocardial Ischemia
Hematologic Agents
Physiological Effects of Drugs
Vascular Diseases

Adjuvants, Immunologic
Arteriosclerosis
Pharmacologic Actions
Coronary Disease
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 10, 2009