Have stable coronary artery disease (i.e. no acute event like myocardial infarction or PTCA less then 3 months ago)
Conditions
Interventions
Product Name: Niaspan
Pharmaceutical Form: Tablet
INN or Proposed INN: Niacin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Product Name: Sortis
Pharmaceuti
Sponsors
Medical Department I
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Be at least 18 years old, male or female (2) Have stable coronary artery disease (i.e. no acute event like myocardial infarction or PTCA less then 3 months ago) (3) LDL > 70 mg/dl (4) HDL =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) Women of childbearing potential, pregnancy or being lactating (2) Current participation in another clinical trial (3) Have other severe concurrent illness (e.g., active infection, malignancy) (4) Have a history of alcohol or drug abuse within 3 months of admission or factors making follow-up difficult or unlikely. (5) Have significant or unexplained liver dysfunction or chronic increased levels of transaminases (ALT, AST) (6) Suffer from myopathy, active peptic disease or arterial bleeding (7) Have a known hypersensitivity against niacin or statins (8) Are actually treated with any of Itraconezol, Ketoconazol, HIV-Protease-Inhibitors, Erythromycin, Clarythromycin, Telithromycin, Nefazodon. (9) Actual therapy with ezitimibe (10) History of diabetes mellitus type I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We hypothesize that – as a systemic effect – the combined application of niacin with statins enhances the number and functional capacity of EPCs and other stem cell populations in the peripheral blood as well as adiponectin plasma level and lowers hsCRP more than statins alone, which may result in a better long-term outcome of CAD. Primary endpoints are numbers of EPCs and inflammatory markers, adiponectin and hsCRP after 12 weeks.;Secondary Objective: Secondary endpoints are numbers of EPCs and inflammatory markers, adiponectin and hsCRP after 4 weeks as well as number and type of progenitor cells, dendritic cells, cytokines, lipoproteins in peripheral blood and vascular function after 8 and 12 weeks. ;Primary end point(s): Primary endpoints are numbers of EPCs and inflammatory markers, adiponectin and hsCRP after 12 weeks. | — |
Countries
Germany
Outcome results
None listed