Coronary Artery DiseasePhase 2NCT00431145
Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)
A Phase 2 study testing Niacin and Niacin+Statin in people with Coronary Artery Disease, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Niacin and Niacin+Statin
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 -
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Niacin, Niacin+Statin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiacinDrug
Niacin+StatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of EPCs and inflammatory markers
adiponectin
hsCRP
each after 8 weeks
Secondary outcomes (15)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Wolfgang M Franz, MD, Principal investigator, University of Munich/Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431145
- Sponsor's protocol ID
- 20091977
- Status last verified
- Feb 2007
- First submitted
- 1 Feb 2007
- Last updated
- 5 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 -
- ClinicalTrials.gov ID
- NCT00431145
- Acronym / sponsor ID
- 20091977
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Oct 2006
- First posted
- 5 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niacin | Drug | – |
| Niacin+Statin | Drug | – |
Primary outcome
numbers of EPCs and inflammatory markers
adiponectin
hsCRP
each after 8 weeks
15 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang M Franz, MD principal investigator
University of Munich/Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niacin and Niacin+Statin in people with Coronary Artery Disease, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang M Franz, MD (++498970956095, Wolfgang.Franz@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numbers of EPCs and inflammatory markers. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2007.