NCT00641758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 10, 2010

Status Verified

February 1, 2010

Enrollment Period

1.8 years

First QC Date

March 17, 2008

Last Update Submit

February 9, 2010

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Diseaseendothelial dysfunctionNitric oxide

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (1)

  • 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.

    8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Pycnogenol

ACTIVE COMPARATOR
Drug: Pycnogenol

Interventions

PycnogenolDRUG

Pycnogenol 100mg twice daily

Pycnogenol
PlaceboDRUG

Placebo 100mg twice daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 22240497DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

pycnogenols

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Georg Noll, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 24, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 10, 2010

Record last verified: 2010-02

Locations

CH(1)