Status:
COMPLETED
Exercise Versus Niacin in Patients With Coronary Artery Disease (CAD) and Low High-Density Lipoproteins (HDL)
Lead Sponsor:
University of Leipzig
Conditions:
Coronary Disease
Hypolipoproteinemia
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
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 chole...
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 dilatat...
Eligibility Criteria
Inclusion
- Coronary disease
- Low HDL cholesterol
- Age limits (see below)
Exclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00298909
Start Date
March 1 2006
End Date
June 1 2009
Last Update
July 31 2012
Active Locations (1)
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1
University of Leipzig Heart Center
Leipzig, Germany, 04289