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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.
 
ClinicalTrials.gov Identifier: NCT00641758
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : February 10, 2010
Sponsor:
Information provided by:
University of Zurich

Tracking Information
First Submitted Date  ICMJE March 17, 2008
First Posted Date  ICMJE March 24, 2008
Last Update Posted Date February 10, 2010
Study Start Date  ICMJE March 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00641758 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pycnogenol and Endothelial Function in Coronary Artery Disease
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: Pycnogenol
    Pycnogenol 100mg twice daily
  • Drug: Placebo
    Placebo 100mg twice daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Pycnogenol
    Intervention: Drug: Pycnogenol
Publications * Enseleit F, Sudano I, Périat D, Winnik S, Wolfrum M, Flammer AJ, Fröhlich GM, Kaiser P, Hirt A, Haile SR, Krasniqi N, Matter CM, Uhlenhut K, Högger P, Neidhart M, Lüscher TF, Ruschitzka F, Noll G. Effects of Pycnogenol on endothelial function in patients with stable coronary artery disease: a double-blind, randomized, placebo-controlled, cross-over study. Eur Heart J. 2012 Jul;33(13):1589-97. doi: 10.1093/eurheartj/ehr482. Epub 2012 Jan 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 17, 2008)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00641758
Other Study ID Numbers  ICMJE Pycno2007-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. med. Georg Noll, University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Georg Noll, MD University of Zurich
PRS Account University of Zurich
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP