Status:
COMPLETED
Pycnogenol and Endothelial Function in Coronary Artery Disease
Lead Sponsor:
University of Zurich
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 pla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00641758
Start Date
March 1 2008
End Date
December 1 2009
Last Update
February 10 2010
Active Locations (1)
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1
University of Zurich
Zurich, Switzerland, 8091