Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)

Coronary Artery Disease Clinical Trial

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 -

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00431145
• Other study ID #: 20091977
• Status: Recruiting
• Phase: Phase 2
• First received: February 1, 2007
• Last updated: February 1, 2007
• Start date: October 2006

Study information

• Verified date: February 2007
• Source: Ludwig-Maximilians - University of Munich
• Contact: Wolfgang M Franz, MD
• Phone: ++498970956095
• Email: Wolfgang.Franz[@]med.uni-muenchen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Niacin

• Niacin+Statin

Locations

Country	Name	City	State
Germany	University of Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

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