Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)

Ludwig Maximilian University of Munich

Status and phase

Unknown

Phase 2

Conditions

Coronary Artery Disease

Treatments

Drug: Niacin

Drug: Niacin+Statin

Study type

Interventional

Funder types

Other

Identifiers

NCT00431145

20091977

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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