Exercise Versus Niacin in Patients With Coronary Artery Disease (CAD) and Low High-Density Lipoproteins (HDL)
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
1 other identifier
interventional
48
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 2, 2006
CompletedFirst Posted
Study publicly available on registry
March 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJuly 31, 2012
July 1, 2012
3.3 years
March 2, 2006
July 29, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
relative effect on flow-mediated dilatation of radial artery
6 months
Secondary Outcomes (5)
lipid profile
6 months
biochemical markers of atherosclerosis
6 months
expression of monocyte surface markers
6 months
oxidative stress
6 months
thrombogenicity
6 months
Study Arms (3)
1
EXPERIMENTALniacin
2
ACTIVE COMPARATORphysical exercise
3
PLACEBO COMPARATORcontrol
Interventions
Eligibility Criteria
You may qualify if:
- Coronary disease
- Low HDL cholesterol
- Age limits (see below)
You may not qualify if:
- CAD with indication for bypass surgery
- Left main disease ( \> 25% stenosis diameter)
- Ejection fraction \< 40%
- Higher degree heart valve disease
- Higher degree ventricular arrhythmias
- 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
- Allergy against niacin oder other ingredient of niaspan
- Acute gastric ulcer
- Arterial bleeding
- Uncontrolled severe arterial hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Leipzig Heart Center
Leipzig, 04289, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steffen Desch, MD
Heart Center Leipzig - University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Priv.-Doz. Dr. med.
Study Record Dates
First Submitted
March 2, 2006
First Posted
March 3, 2006
Study Start
March 1, 2006
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
July 31, 2012
Record last verified: 2012-07