Coronary DiseasePhase 4NCT00298909
Exercise Versus Niacin in Patients With Coronary Artery Disease (CAD) and Low High-Density Lipoproteins (HDL)
A Phase 4 study testing physical exercise, niaspan (extended-release niacin) and niacin in people with Coronary Disease and Hypolipoproteinemia, run by University of Leipzig at 1 site in Germany.
Trial summary
The investigators want to study the relative effects of physical exercise vs. extended-release niacin (lipid-lowering drug) in patients with coronary heart disease and low HDL cholesterol ("good cholesterol") on lipid profile endothelial function as measured by ultrasound The endothelium is the inner part of the blood… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Coronary Disease, Hypolipoproteinemia
- What is being tested?
- physical exercise, niaspan (extended-release niacin) and niacin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Jun 2009
- Phase
- Phase 4
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary disease
- Low HDL cholesterol
- Age limits (see below)
Who cannot join
- Unstable angina oder MI within 3 months prior to inclusion
- CAD with indication for bypass surgery
- Left main disease ( > 25% stenosis diameter)
- Ejection fraction < 40%
- Higher degree heart valve disease
- Higher degree ventricular arrhythmias
Show all 19Show fewer
- Type 1 Diabetes
- Severe disorders of lipoprotein metabolism (Low-density lipoprotein cholesterol (LDL)> 5.0 mmol/L)
- Severe liver disease
- Thyroid disease
- Alcohol or drug abuse
- Pregnancy
- Stroke or Transient Ischemic Attack (TIA) within 3 months prior to inclusion
- Allergy against niacin oder other ingredient of niaspan
- Participation in other clinical trial within 30 days prior to inclusion
- Acute gastric ulcer
- Arterial bleeding
- Uncontrolled severe arterial hypertension
- Treatment with lipid-lowering drug other than Hydroxy-Methylglutaryl Coenzyme A (HMG-CoA)-inhibitor within 3 months prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Versus Extended-Release Niacin in Patients With Coronary Heart Disease and Low High-Density Lipoproteins (HDL) Cholesterol: Effect on Lipid Profile and Endothelial Function
The investigators want to study the relative effects of physical exercise vs. extended-release niacin (lipid-lowering drug) in patients with coronary heart disease and low HDL cholesterol ("good cholesterol") on
- lipid profile
- endothelial function as measured by ultrasound
Read more
The endothelium is the inner part of the blood vessels. Impaired endothelial function is known to be associated with atherosclerosis which can ultimately lead to diseases such as stroke, heart attack and others. Endothelial function can be assessed non-invasively by ultrasound.
Both interventions mentioned above have been shown to have a beneficial effect on lipid profile and endothelial function. However, the relative effects are unclear.
Read the detailed description
Comparison of physical exercise vs. extended-release niacin in patients with CAD and low HDL cholesterol (< 1,03 mmol/L) on lipid profile and endothelial function as measured by flow-mediated dilatation of radial artery. Secondary goals are the assessment of biochemical markers of atherosclerosis, expression of monocyte surface markers, oxidative stress and thrombogenicity.
- Conditions
- Coronary Disease, Hypolipoproteinemia
- Being tested
- physical exercise, niaspan (extended-release niacin), niacin, control
- Medical subject headings
- Coronary Disease, Hypolipoproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseBehavioural
physical exercise
niaspan (extended-release niacin)Drug
niaspan (extended-release niacin)
niacinDrug
niacin extended-release
controlOther
control
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | niacin Receives: Drug: niaspan (extended-release niacin); Drug: niacin |
| 2 | Active comparator | physical exercise Receives: Behavioral: physical exercise |
| 3 | Placebo comparator | control Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative effect on flow-mediated dilatation of radial artery
Measured: 6 months
Secondary outcomes (5)
lipid profile
Measured: 6 months
biochemical markers of atherosclerosis
Measured: 6 months
expression of monocyte surface markers
Measured: 6 months
oxidative stress
Measured: 6 months
thrombogenicity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffen Desch, MD, University of Leipzig
- Investigators
- Steffen Desch, MD, Principal investigator, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298909
- Sponsor's protocol ID
- Leipzig-02
- Status last verified
- Jul 2012
- First submitted
- 2 Mar 2006
- Last updated
- 31 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Versus Extended-Release Niacin in Patients With Coronary Heart Disease and Low High-Density Lipoproteins (HDL) Cholesterol: Effect on Lipid Profile and Endothelial Function
- ClinicalTrials.gov ID
- NCT00298909
- Acronym / sponsor ID
- Leipzig-02
- Conditions
- Coronary Disease, Hypolipoproteinemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Mar 2006 (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.
The investigators want to study the relative effects of physical exercise vs. extended-release niacin (lipid-lowering drug) in patients with coronary heart disease and low HDL cholesterol ("good cholesterol") on
- lipid profile
- endothelial function as measured by ultrasound
The endothelium is the inner part of the blood vessels. Impaired endothelial function is known to be associated with atherosclerosis which can ultimately lead to diseases such as stroke, heart attack and others. Endothelial function can be assessed non-invasively by ultrasound.
Both interventions mentioned above have been shown to have a beneficial effect on lipid profile and endothelial function. However, the relative effects are unclear.
Detailed description
Comparison of physical exercise vs. extended-release niacin in patients with CAD and low HDL cholesterol (< 1,03 mmol/L) on lipid profile and endothelial function as measured by flow-mediated dilatation of radial artery. Secondary goals are the assessment of biochemical markers of atherosclerosis, expression of monocyte surface markers, oxidative stress and thrombogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: niaspan (extended-release niacin), Drug: niacinniacin |
| 2 | Active comparator | Behavioral: physical exercisephysical exercise |
| 3 | Placebo comparator | Other: controlcontrol |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Coronary disease
- Low HDL cholesterol
- Age limits (see below)
Key exclusion criteria (19 listed)
- Unstable angina oder MI within 3 months prior to inclusion
- CAD with indication for bypass surgery
- Left main disease ( > 25% stenosis diameter)
- Ejection fraction < 40%
- Higher degree heart valve disease
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 |
|---|---|---|
| physical exercisephysical exercise | Behavioural | 2 |
| niaspan (extended-release niacin)niaspan (extended-release niacin) | Drug | 1 |
| niacinniacin extended-release | Drug | 1 |
| controlcontrol | Other | 3 |
Primary outcome
relative effect on flow-mediated dilatation of radial artery
Time frame: 6 months
5 secondary outcomes
lipid profile
Time frame: 6 months
biochemical markers of atherosclerosis
Time frame: 6 months
expression of monocyte surface markers
Time frame: 6 months
oxidative stress
Time frame: 6 months
thrombogenicity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
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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.
Steffen Desch, MD principal investigator
Heart Center Leipzig - University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing physical exercise, niaspan (extended-release niacin) and niacin in people with Coronary Disease and Hypolipoproteinemia, run by University of Leipzig 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 3 inclusion and 19 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: finished, as of the sponsor's last update on 31 Jul 2012. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative effect on flow-mediated dilatation of radial artery (time frame: 6 months). 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 31 Jul 2012.