Pycnogenol and Endothelial Function in Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00641758
First received: March 17, 2008
Last updated: February 9, 2010
Last verified: February 2010
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

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
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo 100mg twice daily
Active Comparator: Pycnogenol 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Switzerland
University of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Georg Noll, MD University of Zurich
  More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. med. Georg Noll, University of Zurich
ClinicalTrials.gov Identifier: NCT00641758     History of Changes
Other Study ID Numbers: Pycno2007-003
Study First Received: March 17, 2008
Last Updated: February 9, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Coronary Artery Disease
endothelial dysfunction
Nitric oxide

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pycnogenols
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014