Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00431145
First received: February 1, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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 Intervention Phase
Coronary Artery Disease
Drug: Niacin
Drug: Niacin+Statin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 -

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • numbers of EPCs and inflammatory markers
  • adiponectin
  • hsCRP
  • each after 8 weeks

Secondary Outcome Measures:
  • numbers of EPCs,
  • inflammatory markers
  • adiponectin
  • hsCRP
  • each after 4 weeks
  • number and type of progenitor cells
  • dendritic cells
  • cytokines
  • lipoproteins in peripheral blood
  • vascular function
  • each after 4 and 8 weeks
  • carotid artery distensibility
  • carotid artery plaque composition
  • each after 8 weeks
  • optionally 1 year follow-up

Estimated Enrollment: 80
Study Start Date: October 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431145

Contacts
Contact: Wolfgang M Franz, MD ++498970956095 Wolfgang.Franz@med.uni-muenchen.de
Contact: Hans D Theiss, MD ++498970953074 Hans.Theiss@med.uni-muenchen.de

Locations
Germany
University of Munich Recruiting
Munich, Germany, 80333
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Wolfgang M Franz, MD University of Munich/Germany
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00431145     History of Changes
Other Study ID Numbers: 20091977
Study First Received: February 1, 2007
Last Updated: February 1, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 16, 2014