- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00641758
Pycnogenol and Endothelial Function in Coronary Artery Disease
February 9, 2010 updated by: University of Zurich
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland, 8091
- University of Zurich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo 100mg twice daily
|
Active Comparator: Pycnogenol
|
Pycnogenol 100mg twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Georg Noll, MD, University of Zurich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
March 17, 2008
First Submitted That Met QC Criteria
March 17, 2008
First Posted (Estimate)
March 24, 2008
Study Record Updates
Last Update Posted (Estimate)
February 10, 2010
Last Update Submitted That Met QC Criteria
February 9, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Immunologic Factors
- Protective Agents
- Adjuvants, Immunologic
- Antioxidants
- Pycnogenols
Other Study ID Numbers
- Pycno2007-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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