Coronary artery disease (CAD) and known dyslipidemia Circulatory System Coronary artery disease (CAD) and known dyslipidemia
Conditions
Interventions
Twelve weeks oral Niacin therapy
Sponsors
Johannes Gutenberg-University Mainz (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women > 35 and 70 mg/dl) and a high density lipoprotein cholesterol (HDL <65mg/dl) 3. A flow-mediated vasodilatation (FMD) of less than 8% 4. Ability of subject to understand character and individual consequences of clinical trial 5. Written informed consent must be available before enrolment in the trial 6. For women with childbearing potential, adequate contraception
Exclusion criteria
Exclusion criteria: 1. Clinical signs of congestive heart failure or left ventricular ejection fraction 180/110mmHg) or hypotension (systolic blood pressure 2.5 mg/dl) 7. Known hepatic disease or elevation of serum transaminases or gamma glutamyl transferase (gGT) > 2x ULN (upper limit of normal range) 8. Uric acid >10.0 mg/dl 9. Alcohol abuse 10. White blood cell (WBC) count >12,000 or platelet count >500,000 /ul or <75,000 /ul 11. Existence of acute gastric ulcers 12. Existence of acute arterial bleeding 13. Other significant laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of 12 weeks oral niacin therapy in addition to standard long-term CAD medication on flow dependent vasodilation (FMD) in patients suffering from CAD | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects of niacin therapy on plasma lipid composition, HDL-C levels, LDL, triglycerides, total cholesterol, cholesterol ratio, high sensitivity C-reactive protein (hs-CRP), cardiovascular biomarkers, endothelium-independent nitrogylcerin-induced vasodilation (NMD) and FMD levels. | — |
Countries
Germany
Outcome results
None listed