The Role of Atorvastatin on Monocyte Function in Patients With Coronary Artery Disease and Hypercholesterolemia

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

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2006-03-31

Brief Summary

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The aim of this study is to determine, whether an intensified atorvastatin therapy can improve monocyte function in patients with coronary artery disease and hypercholesterolemia.

Detailed Description

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Hypercholesterolemia is one of the most important cardiovascular risk factors that significantly elevates the risk for the development and progression of arteriosclerotic diseases.

Statins such as atorvastatin have been shown to reduce atherogenic lipoprotein levels as well as cardiovascular morbidity and mortality in a large number of clinical trials. It is suggested that statins have- apart from their lipid-lowering properties- other pleiotropic effects that are responsible for their anti-atheroslerotic and and cardioprotective potential.

Monocytes are crucially involved in the process of arteriogenesis (i.e. the growth of preexisting arterioles). Monocyte chemotaxis can be stimulated with arteriogenic molecules such as vascular endothelial growth factor A (VEGF-A). In previous studies we could demonstrate that the VEGF-A- induced monocyte chemotaxis is severely impaired in hypercholesterolemic patients. This reduced response to VEGF seems to be associated with a decreased ability to form functional collaterals.

Therefore we hypothesize that an intensified therapy with atorvastatin 40 mg once a day can significantly improve monocyte function in patients with coronary artery disease and hypercholesterolemia compared to patients who are only treated with a placebo.

Conditions

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Coronary Artery Disease Hypercholesterolemia Monocyte Function

Keywords

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statin atorvastatin hypercholesterolemia coronary artery disease monocyte collateral formation arteriogenesis chemotaxis migration growth factors vascular endothelial growth factor A placenta growth factor 1 hepatocyte growth factor monocyte chemotactic protein 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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atorvastatin (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* coronary artery disease (angiographically proven)
* diagnosis of hypercholesterolemia (either LDL-C ≥ 4 mmol/l or already treated with lipid-lowering medication)

Exclusion Criteria

* diabetes mellitus
* uncontrolled arterial hypertension (repeated BP ≥ 160/90 mmHg)
* smoking
* active infections
* acute coronary syndrome (\< 8 weeks)
* malignant diseases
* nephropathy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Johannes Waltenberger, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ulm, Germay

Locations

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University Hospital Ulm

Ulm, , Germany

Site Status

Countries

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Germany

References

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Waltenberger J, Lange J, Kranz A. Vascular endothelial growth factor-A-induced chemotaxis of monocytes is attenuated in patients with diabetes mellitus: A potential predictor for the individual capacity to develop collaterals. Circulation. 2000 Jul 11;102(2):185-90. doi: 10.1161/01.cir.102.2.185.

Reference Type BACKGROUND

PMID: 10889129 (View on PubMed)

Other Identifiers

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ATV-D-01-007 G

Identifier Type: -

Identifier Source: org_study_id