Pycnogenol and Endothelial Function in Coronary Artery Disease
This study has been completed.
Sponsor:
University of Zurich
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00641758
First received: March 17, 2008
Last updated: February 9, 2010
Last verified: February 2010
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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) |
Resource links provided by NLM:
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 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 May 19, 2013