Pycnogenol and Endothelial Function in Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Pycnogenol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, endothelial dysfunction, Nitric oxide
Eligibility 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
Sites / Locations
- University of Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Pycnogenol
Arm Description
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00641758
Brief Title
Pycnogenol and Endothelial Function in Coronary Artery Disease
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 Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, endothelial dysfunction, Nitric oxide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Pycnogenol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pycnogenol
Intervention Description
Pycnogenol 100mg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 100mg twice daily
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Noll, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22240497
Citation
Enseleit F, Sudano I, Periat D, Winnik S, Wolfrum M, Flammer AJ, Frohlich GM, Kaiser P, Hirt A, Haile SR, Krasniqi N, Matter CM, Uhlenhut K, Hogger P, Neidhart M, Luscher 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.
Results Reference
derived
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Pycnogenol and Endothelial Function in Coronary Artery Disease
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