Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)

NCT00431145 | Unknown Phase 2

• 1 other identifier: 20091977
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (4)

• numbers of EPCs and inflammatory markers

• adiponectin

• hsCRP

• each after 8 weeks

Secondary Outcomes (15)

• numbers of EPCs,

• inflammatory markers

• adiponectin

• hsCRP

• each after 4 weeks

Interventions

Niacin DRUG

Niacin+Statin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

University of Munich

Munich, 80333, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Niacin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Wolfgang M Franz, MD

  University of Munich/Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang M Franz, MD

CONTACT

++498970956095; Wolfgang.Franz@med.uni-muenchen.de

Hans D Theiss, MD

CONTACT

++498970953074; Hans.Theiss@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2007
• First Posted: February 5, 2007
• Study Start: October 1, 2006
• Last Updated: February 5, 2007

Record last verified: 2007-02

Locations

DE (1)