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

NCT ID: NCT00298909

Last Updated: 2012-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Coronary Disease Hypolipoproteinemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

niacin

Group Type EXPERIMENTAL

niaspan (extended-release niacin)

Intervention Type DRUG

niaspan (extended-release niacin)

niacin

Intervention Type DRUG

niacin extended-release

2

physical exercise

Group Type ACTIVE_COMPARATOR

physical exercise

Intervention Type BEHAVIORAL

physical exercise

3

control

Group Type PLACEBO_COMPARATOR

control

Intervention Type OTHER

control

Interventions

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physical exercise

physical exercise

Intervention Type BEHAVIORAL

niaspan (extended-release niacin)

niaspan (extended-release niacin)

Intervention Type DRUG

niacin

niacin extended-release

Intervention Type DRUG

control

control

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Steffen Desch, MD

Priv.-Doz. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steffen Desch, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig - University Hospital

Locations

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University of Leipzig Heart Center

Leipzig, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Leipzig-02

Identifier Type: -

Identifier Source: org_study_id