Coronary Artery Disease
Conditions
Brief summary
Aim of the study is to show additional effects of the combined therapy of niacin and statins analyzing number and function of EPCs and other stem cell populations and adiponectin as well as hsCRP levels in patients with CAD.
Interventions
DRUGNiacin
DRUGNiacin+Statin
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years old, male or female * Have stable coronary artery disease (i.e. no acute event like myocardial infarction or PTCA less then 3 months ago) * LDL \> 100 mg/dl * HDL \< 50 mg/dl * Triglycerides \< 400 mg/dl * No Nicotine abuse for at least 3 months * Statin-therapy for more than 4 weeks * Give a written informed consent * Have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.
Exclusion criteria
* Women of childbearing potential, pregnancy or being lactating * Current participation in another clinical trial * Have other severe concurrent illness (e.g., active infection, malignancy) * Have a history of alcohol or drug abuse within 3 months of admission or factors making follow-up difficult or unlikely. * Have significant or unexplained liver dysfunction or chronic increased levels of transaminases (ALT, AST) * Suffer from myopathy, active peptic disease or arterial bleeding * Have a known hypersensitivity against niacin or statins * Are actually treated with any of itraconazole, ketoconazole, HIV-Protease-Inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone. * Actual therapy with ezetimibe * Diabetes mellitus Type I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| numbers of EPCs and inflammatory markers | — |
| adiponectin | — |
| hsCRP | — |
| each after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| each after 4 weeks | — |
| number and type of progenitor cells | — |
| dendritic cells | — |
| cytokines | — |
| lipoproteins in peripheral blood | — |
| numbers of EPCs, | — |
| each after 4 and 8 weeks | — |
| carotid artery distensibility | — |
| carotid artery plaque composition | — |
| each after 8 weeks | — |
| optionally 1 year follow-up | — |
| vascular function | — |
| inflammatory markers | — |
| adiponectin | — |
| hsCRP | — |
Countries
Germany
Contacts
Primary ContactWolfgang M Franz, MD
Backup ContactHans D Theiss, MD
Outcome results
None listed