Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Niacin
Niacin+Statin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility 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
Sites / Locations
- University of MunichRecruiting
Outcomes
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
Full Information
NCT ID
NCT00431145
First Posted
February 1, 2007
Last Updated
February 1, 2007
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT00431145
Brief Title
Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Niacin
Intervention Type
Drug
Intervention Name(s)
Niacin+Statin
Primary Outcome Measure Information:
Title
numbers of EPCs and inflammatory markers
Title
adiponectin
Title
hsCRP
Title
each after 8 weeks
Secondary Outcome Measure Information:
Title
numbers of EPCs,
Title
inflammatory markers
Title
adiponectin
Title
hsCRP
Title
each after 4 weeks
Title
number and type of progenitor cells
Title
dendritic cells
Title
cytokines
Title
lipoproteins in peripheral blood
Title
vascular function
Title
each after 4 and 8 weeks
Title
carotid artery distensibility
Title
carotid artery plaque composition
Title
each after 8 weeks
Title
optionally 1 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfgang M Franz, MD
Phone
++498970956095
Email
Wolfgang.Franz@med.uni-muenchen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Hans D Theiss, MD
Phone
++498970953074
Email
Hans.Theiss@med.uni-muenchen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang M Franz, MD
Organizational Affiliation
University of Munich/Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Munich
City
Munich
ZIP/Postal Code
80333
Country
Germany
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)
We'll reach out to this number within 24 hrs