Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Combined Therapy of Niacin and Statins on Stem Cell Mobilization and Inflammatory Parameters in Patients Suffering From Coronary Artery Disease - Randomized Clinical Study -

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Niacin
* Drug: Niacin+Statin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Niacin|nan|
|Drug: Niacin+Statin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numbers of EPCs and inflammatory markers |  |  | 
| adiponectin |  |  | 
| hsCRP |  |  | 
| each after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numbers of EPCs, |  |  | 
| inflammatory markers |  |  | 
| adiponectin |  |  | 
| hsCRP |  |  | 
| each after 4 weeks |  |  | 
| number and type of progenitor cells |  |  | 
| dendritic cells |  |  | 
| cytokines |  |  | 
| lipoproteins in peripheral blood |  |  | 
| vascular function |  |  | 
| each after 4 and 8 weeks |  |  | 
| carotid artery distensibility |  |  | 
| carotid artery plaque composition |  |  | 
| each after 8 weeks |  |  | 
| optionally 1 year follow-up |  |  |