Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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Aim of the study is to show additional effects of the combined therapy of niacin and statins analyzing number and function of EPCs and other stem cell populations and adiponectin as well as hsCRP levels in patients with CAD.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Niacin

Intervention Type DRUG

Niacin+Statin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Be at least 18 years old, male or female
* Have stable coronary artery disease (i.e. no acute event like myocardial infarction or PTCA less then 3 months ago)
* LDL \> 100 mg/dl
* HDL \< 50 mg/dl
* Triglycerides \< 400 mg/dl
* No Nicotine abuse for at least 3 months
* Statin-therapy for more than 4 weeks
* Give a written informed consent
* Have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.

Exclusion Criteria

* Women of childbearing potential, pregnancy or being lactating
* Current participation in another clinical trial
* Have other severe concurrent illness (e.g., active infection, malignancy)
* Have a history of alcohol or drug abuse within 3 months of admission or factors making follow-up difficult or unlikely.
* Have significant or unexplained liver dysfunction or chronic increased levels of transaminases (ALT, AST)
* Suffer from myopathy, active peptic disease or arterial bleeding
* Have a known hypersensitivity against niacin or statins
* Are actually treated with any of itraconazole, ketoconazole, HIV-Protease-Inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone.
* Actual therapy with ezetimibe
* Diabetes mellitus Type I

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No