Exercise Versus Niacin in Patients With Coronary Artery Disease (CAD) and Low High-Density Lipoproteins (HDL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steffen Desch, MD, University of Leipzig
ClinicalTrials.gov Identifier:
NCT00298909
First received: March 2, 2006
Last updated: July 29, 2012
Last verified: July 2012

March 2, 2006
July 29, 2012
March 2006
June 2009   (final data collection date for primary outcome measure)
relative effect on flow-mediated dilatation of radial artery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
relative effect on flow-mediated dilatation of radial artery
Complete list of historical versions of study NCT00298909 on ClinicalTrials.gov Archive Site
  • lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • biochemical markers of atherosclerosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • expression of monocyte surface markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • oxidative stress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • thrombogenicity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • relative effect on
  • - lipid profile
  • - biochemical markers of atherosclerosis
  • - expression of monocyte surface markers
  • - oxidative stress
  • - thrombogenicity
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Disease
  • Hypolipoproteinemia
  • Behavioral: physical exercise
    physical exercise
  • Drug: niaspan (extended-release niacin)
    niaspan (extended-release niacin)
  • Drug: niacin
    niacin extended-release
  • Other: control
    control
  • Experimental: 1
    niacin
    Interventions:
    • Drug: niaspan (extended-release niacin)
    • Drug: niacin
  • Active Comparator: 2
    physical exercise
    Intervention: Behavioral: physical exercise
  • Placebo Comparator: 3
    control
    Intervention: Other: control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Coronary disease
  • Low HDL cholesterol
  • Age limits (see below)

Exclusion Criteria:

  • 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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00298909
Leipzig-02
Not Provided
Steffen Desch, MD, University of Leipzig
University of Leipzig
Not Provided
Principal Investigator: Steffen Desch, MD University of Leipzig
University of Leipzig
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP