Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT00641758
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00641758
Study Brief:
Protocol Section:
NCT00641758