Women or men > 35 and < 80 years of age with a documented, clinically stable coronary artery disease (CAD) and a flow-mediated vasodilatation (FMD) of less than 8% from the heart catheter register of the department of medicine II, Johannes Gutenberg-University Mainz.
Conditions
Interventions
Trade Name: Niaspan
Pharmaceutical Form: Capsule*
INN or Proposed INN: nicotinic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 375-
Pharmaceutical form of th
Sponsors
Johannes Gutenberg-Universität Mainz, II. Med. Klinik (ausführende Stelle), Prof. Dr. med. T. Münzel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men or women > 35 and 70 mg/dl and a HDL-Cholesterol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Clinical signs of congestive heart failure or left ventricular ejection fraction 180/110mmHg) or hypotension (systolic blood pressure 2.5 mg/dl) - Known hepatic disease or elevation of serum transaminases or gGT > 2x ULN (upper limit of normal range) - Uric acid >10,0 mg/dl - Alcohol abuse - WBC >12.000 or platelet count >500.000/µl or <75.000/µl - Existence of acute gastric ulcers - Existence of acute arterial bleeding - Other significant laboratory abnormalities that the investigator feels may compromise the patient’s safety by participation in the study - History of systemic inflammatory disease (rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, systemic lupus erythematous), myositis/myopathic process, or cancer - Known HIV - Malabsorption - Overt hyperthyreodism - Pregnancy and lactation - 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 - Participation in other clinical trials and observation period of competing trials, respectively
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effect of an 12 weeks oral niacin therapy in addition to standard long-term CAD medication on flow dependent vasodilation (FMD) in patients. ;Secondary Objective: Effects of niacin therapy on plasma lipid composition, HDL-C levels, LDL, trigylcerides, total cholesterol, cholesterol ratio, hs-CRP, cardiovascular biomarkers, endothelium-independent nitroglycerin-induced vasodilation (NMD) and FMD levels. ;Primary end point(s): Primary endpoint is the absolute change in FMD from baseline to 12 weeks-follow-up. | — |
Countries
Germany
Outcome results
None listed