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Pycnogenol and Endothelial Function in Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00641758
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : February 10, 2010
Information provided by:
University of Zurich

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Pycnogenol Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo 100mg twice daily

Active Comparator: Pycnogenol Drug: Pycnogenol
Pycnogenol 100mg twice daily

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00641758

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University of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Georg Noll, MD University of Zurich
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. med. Georg Noll, University of Zurich Identifier: NCT00641758    
Other Study ID Numbers: Pycno2007-003
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: February 2010
Keywords provided by University of Zurich:
Coronary Artery Disease
endothelial dysfunction
Nitric oxide
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Platelet Aggregation Inhibitors