Status:
UNKNOWN
Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 leve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00431145
Start Date
October 1 2006
Last Update
February 5 2007
Active Locations (1)
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1
University of Munich
Munich, Germany, 80333