Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)

February 1, 2007 updated by: Ludwig-Maximilians - University of Munich

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 -

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Munich, Germany, 80333
        • Recruiting
        • University of Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
numbers of EPCs and inflammatory markers
adiponectin
hsCRP
each after 8 weeks

Secondary Outcome Measures

Outcome Measure
inflammatory markers
adiponectin
hsCRP
each after 8 weeks
numbers of EPCs,
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
optionally 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Investigators

  • Principal Investigator: Wolfgang M Franz, MD, University of Munich/Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Registration Dates

First Submitted

February 1, 2007

First Submitted That Met QC Criteria

February 1, 2007

First Posted (Estimate)

February 5, 2007

Study Record Updates

Last Update Posted (Estimate)

February 5, 2007

Last Update Submitted That Met QC Criteria

February 1, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20091977

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Niacin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe