Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00431145
Recruitment Status : Unknown
Verified February 2007 by Ludwig-Maximilians - University of Munich.
Recruitment status was:  Recruiting
First Posted : February 5, 2007
Last Update Posted : February 5, 2007
Information provided by:
Ludwig-Maximilians - University of Munich

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Niacin Drug: Niacin+Statin Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 -
Study Start Date : October 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. numbers of EPCs and inflammatory markers
  2. adiponectin
  3. hsCRP
  4. each after 8 weeks

Secondary Outcome Measures :
  1. numbers of EPCs,
  2. inflammatory markers
  3. adiponectin
  4. hsCRP
  5. each after 4 weeks
  6. number and type of progenitor cells
  7. dendritic cells
  8. cytokines
  9. lipoproteins in peripheral blood
  10. vascular function
  11. each after 4 and 8 weeks
  12. carotid artery distensibility
  13. carotid artery plaque composition
  14. each after 8 weeks
  15. optionally 1 year follow-up

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00431145

Contact: Wolfgang M Franz, MD ++498970956095
Contact: Hans D Theiss, MD ++498970953074

University of Munich Recruiting
Munich, Germany, 80333
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Principal Investigator: Wolfgang M Franz, MD University of Munich/Germany Identifier: NCT00431145     History of Changes
Other Study ID Numbers: 20091977
First Posted: February 5, 2007    Key Record Dates
Last Update Posted: February 5, 2007
Last Verified: February 2007

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Nicotinic Acids
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs