The Role of Atorvastatin on Monocyte Function in Patients With Coronary Artery Disease and Hypercholesterolemia - Full Text View

Sponsor:	University of Ulm
Collaborator:	Pfizer
Information provided by:	University of Ulm
ClinicalTrials.gov Identifier:	NCT00329069

Purpose

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.

Condition	Intervention
Coronary Artery Disease Hypercholesterolemia Monocyte Function	Drug: atorvastatin (drug)

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic
Official Title:	Vascular Endothelial Receptor Activity in Patients With Coronary Artery Disease on Medication With Statins

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Statins

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by University of Ulm:

Primary Outcome Measures:

VEGF-A induced monocyte chemotaxis after 1-month treatment with atorvastatin 40 mg or a placebo once a day
PlGF-1 induced monocyte chemotaxis after 1-month treatment with atorvastatin 40 mg or a placebo once a day
HGF-induced monocyte chemotaxis after 1-month treatment with atorvastatin 40 mg or a placebo once a day
MCP-1-induced monocyte chemotaxis after 1-month treatment with atorvastatin 40 mg or a placebo once a day
VEGF-A+MCP-1-induced monocyte chemotaxis after 1-month treatment with atorvastatin 40 mg or a placebo once a day

Secondary Outcome Measures:

HGF+MCP-1-induced monocyte chemotaxis after 1-month treatment with atorvastatin 40 mg or a placebo once a day

Estimated Enrollment:	50
Study Start Date:	May 2002
Estimated Study Completion Date:	March 2006

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329069

Locations

Germany
University Hospital Ulm
Ulm, Germany, 89081

Sponsors and Collaborators

University of Ulm

Pfizer

Investigators

Principal Investigator:

Johannes Waltenberger, MD PhD

University of Ulm, Germay

More Information

Publications:

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.

Study ID Numbers:	ATV-D-01-007 G
Study First Received:	May 22, 2006
Last Updated:	May 22, 2006
ClinicalTrials.gov Identifier:	NCT00329069 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:

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

Additional relevant MeSH terms:

Antimetabolites
Arterial Occlusive Diseases
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Myocardial Ischemia
Vascular Diseases
Enzyme Inhibitors
Anticholesteremic Agents

Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Coronary Disease
Therapeutic Uses
Cardiovascular Diseases
Hypercholesterolemia
Atorvastatin
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on March 18, 2010