Pycnogenol and Endothelial Function in Coronary Artery Disease

NCT ID: NCT00641758

Last Updated: 2010-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 100mg twice daily

Pycnogenol

Group Type: ACTIVE_COMPARATOR

Pycnogenol

Intervention Type: DRUG

Pycnogenol 100mg twice daily

Interventions

Pycnogenol

Pycnogenol 100mg twice daily

Intervention Type: DRUG

Placebo

Placebo 100mg twice daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

University of Zurich

Principal Investigators

Georg Noll, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University of Zurich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 22240497 (View on PubMed)

Other Identifiers

Pycno2007-003

Identifier Type: -

Identifier Source: org_study_id