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

Tracking Information

First Received Date ^ICMJE

March 2, 2006

Last Updated Date

July 29, 2012

Start Date ^ICMJE

March 2006

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

relative effect on flow-mediated dilatation of radial artery

Change History

Complete list of historical versions of study NCT00298909 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

relative effect on
- lipid profile
- biochemical markers of atherosclerosis
- expression of monocyte surface markers
- oxidative stress
- thrombogenicity

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Coronary Disease
Hypolipoproteinemia

Intervention ^ICMJE

Behavioral: physical exercise
physical exercise
Drug: niaspan (extended-release niacin)
niaspan (extended-release niacin)
Drug: niacin
niacin extended-release
Other: control
control

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

35 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00298909

Other Study ID Numbers ^ICMJE

Leipzig-02

Has Data Monitoring Committee

Not Provided

Responsible Party

Steffen Desch, MD, University of Leipzig

Study Sponsor ^ICMJE

University of Leipzig

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Steffen Desch, MD

University of Leipzig

Information Provided By

University of Leipzig

Verification Date

July 2012

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

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