Coronary Artery DiseaseNCT00641758
Pycnogenol and Endothelial Function in Coronary Artery Disease
A study testing Pycnogenol in people with Coronary Artery Disease, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Pycnogenol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Pycnogenol, Placebo
- Keywords
- Coronary Artery Disease, endothelial dysfunction, Nitric oxide
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PycnogenolDrug
Pycnogenol 100mg twice daily
PlaceboDrug
Placebo 100mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Pycnogenol | Active comparator | Not described Receives: Drug: Pycnogenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Georg Noll, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641758
- Sponsor's protocol ID
- Pycno2007-003
- Status last verified
- Feb 2010
- First submitted
- 17 Mar 2008
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22240497
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00641758
- Acronym / sponsor ID
- Pycno2007-003
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, endothelial dysfunction, Nitric oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Pycnogenol | Active comparator | Drug: Pycnogenol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PycnogenolPycnogenol 100mg twice daily | Drug | Pycnogenol |
| PlaceboPlacebo 100mg twice daily | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2010.
- Derived from this study: PubMed 22240497Enseleit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Noll, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pycnogenol in people with Coronary Artery Disease, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00641758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2010.