search
Back to results

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
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 17, 2008
Last Updated
February 9, 2010
Sponsor
University of Zurich
search

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

Learn more about this trial

Pycnogenol and Endothelial Function in Coronary Artery Disease

We'll reach out to this number within 24 hrs