Coronary artery disease Circulatory System Coronary artery disease
Conditions
Interventions
Eight weeks of pentaerithrityltetranitrate, 80 mg, 3 x orally per day.
Sponsors
Johannes Gutenberg University of Mainz (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women > 35 and < 80 years of age 2. Documented clinically stable CAD with stable angina pectoris 3. Ability of subject to understand the character and individual consequences of the clinical trial 4. Written informed consent must be available before enrollment in the trial 5. For women with childbearing potential, adequate contraception (oral contraceptives or intrauterine devices) is required
Exclusion criteria
Exclusion criteria: 1. Clinical signs of congestive heart failure or left ventricular ejection fraction 180/110mmHg) or hypotension (systolic blood pressure 2.0 mg/dl, women: > 1.8 mg/dl]) 7. Known hepatic disease or elevation of serum transaminases or gGT > 3 x Upper Limit of Normal range (ULN) 8. White Blood Cells (WBC) >16.000 or platelet count >500.000/µl or <75.000/µl 9. Clinically overt hyperthyreodism 10. Pregnancy and lactation 11. Known intolerance to organic nitrates 12. Known lactose intolerance 13. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product 14. Other significant laboratory abnormalities that the investigator feels may compromise the patient's safety by participation in the study 15. In other clinical trials and observation period of competing trials, respectively
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FMD at baseline and after 8 weeks of treatment, measured by high-resolution ultrasound of the right brachial artery diameter percentage change upon reactive hyperemia after 5 minutes suprasystolic occlusion of the upper arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will also be assessed at baseline and after 8 weeks of treatment: 1. Cardiovascular biomarkers (high-sensitivity C-Reactive Protein [hs-CRP], lipid profile, ferritin, bilirubin, uric acid) 2. Endothelium-independent nitrogylcerin-induced vasodilation (NMD) 3. Endo-PAT2000 (device for assessing endothelial function) reactive hyperemia index | — |
Countries
Germany
Outcome results
None listed