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: Have stable coronary artery disease (i.e. no acute event like myocardial infarction or PTCA less then 3 months ago)

Registration Number: EUCTR2005-003093-21-DE

Lead Sponsor: Medical Department I

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

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 < 50 mg/dl
(5) Triglycerides < 400 mg/dl
(6) No Nicotine abuse for at least 3 months
(7) Statin-therapy for more than 4 weeks
(8) Give a written informed consent.
(9) Have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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