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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Disease
Hypolipoproteinemia
 Behavioral: physical exercise
Drug: niaspan (extended-release niacin)
Drug: niacin
Other: control
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • relative effect on flow-mediated dilatation of radial artery [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: March 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
niacin
 Drug: niaspan (extended-release niacin)
niaspan (extended-release niacin)
Drug: niacin
niacin extended-release
Active Comparator: 2
physical exercise
 Behavioral: physical exercise
physical exercise
Placebo Comparator: 3
control
 Other: control
control

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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298909

Locations
Germany
University of Leipzig Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Steffen Desch, MD University of Leipzig
  More Information

No publications provided

Responsible Party: Steffen Desch, MD, Priv.-Doz. Dr. med., University of Leipzig
ClinicalTrials.gov Identifier: NCT00298909     History of Changes
Other Study ID Numbers: Leipzig-02
Study First Received: March 2, 2006
Last Updated: July 29, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypolipoproteinemias
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
 Niacin
Nicotinic Acids
Niacinamide
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013