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

May 22, 2006 updated by: University of Ulm

Vascular Endothelial Receptor Activity in Patients With Coronary Artery Disease on Medication With Statins

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89081
        • University Hospital Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Collaborators

Pfizer

Investigators

  • Principal Investigator: Johannes Waltenberger, MD PhD, University of Ulm, Germay

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

May 22, 2006

First Submitted That Met QC Criteria

May 22, 2006

First Posted (Estimate)

May 24, 2006

Study Record Updates

Last Update Posted (Estimate)

May 24, 2006

Last Update Submitted That Met QC Criteria

May 22, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATV-D-01-007 G

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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