Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Unknown status

CT.gov ID

NCT00431145

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Niacin Drug: Niacin+Statin	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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 -

Study Start Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

numbers of EPCs and inflammatory markers []
adiponectin []
hsCRP []
each after 8 weeks []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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