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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00329069
First received: May 22, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  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
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:


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:
ClinicalTrials.gov Identifier: NCT00329069     History of Changes
Other Study ID Numbers: ATV-D-01-007 G
Study First Received: May 22, 2006
Last Updated: May 22, 2006
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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypercholesterolemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014