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

Coronary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298909
• Other study ID #: Leipzig-02
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2006
• Last updated: July 29, 2012
• Start date: March 2006
• Est. completion date: June 2009

Study information

• Verified date: July 2012
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hypolipoproteinemia
• Hypolipoproteinemias

Intervention

Behavioral:
• physical exercise
physical exercise

Drug:
• niaspan (extended-release niacin)
niaspan (extended-release niacin)
• niacin
niacin extended-release

Other:
• control
control

Locations

Country	Name	City	State
Germany	University of Leipzig Heart Center	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative effect on flow-mediated dilatation of radial artery		6 months	No
Secondary	lipid profile		6 months	No
Secondary	biochemical markers of atherosclerosis		6 months	No
Secondary	expression of monocyte surface markers		6 months	No
Secondary	oxidative stress		6 months	No
Secondary	thrombogenicity		6 months	No