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
Recruitment status was Recruiting
Sponsor:
Ludwig-Maximilians - University of Munich
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
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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:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Niacin Nicotinic Acids Niacinamide 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 May 23, 2013