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

Information source: University of Leipzig
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Disease; Hypolipoproteinemia

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

Phase: Phase 4

Status: Completed

Sponsored by: University of Leipzig

Official(s) and/or principal investigator(s):
Steffen Desch, MD, Principal Investigator, Affiliation: University of Leipzig Heart Center

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.

Clinical Details

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

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

Primary outcome: relative effect on flow-mediated dilatation of radial artery

Secondary outcome:

lipid profile

biochemical markers of atherosclerosis

expression of monocyte surface markers

oxidative stress

thrombogenicity

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

Minimum age: 35 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

University of Leipzig Heart Center, Leipzig 04289, Germany
Additional Information

Starting date: March 2006
Last updated: July 29, 2012

Page last updated: August 23, 2015

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