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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329069
• Other study ID #: ATV-D-01-007 G
• Status: Completed
• Phase: N/A
• First received: May 22, 2006
• Last updated: May 22, 2006
• Start date: May 2002
• Est. completion date: March 2006

Study information

• Verified date: May 2006
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hypercholesterolemia
• Monocyte Function
• Myocardial Ischemia

Intervention

Drug:
• atorvastatin (drug)

Locations

Country	Name	City	State
Germany	University Hospital Ulm	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	Pfizer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VEGF-A induced monocyte chemotaxis after 1-month treatment with atorvastatin 40 mg or a placebo once a day
Primary	PlGF-1 induced monocyte chemotaxis after 1-month treatment with atorvastatin 40 mg or a placebo once a day
Primary	HGF-induced monocyte chemotaxis after 1-month treatment with atorvastatin 40 mg or a placebo once a day
Primary	MCP-1-induced monocyte chemotaxis after 1-month treatment with atorvastatin 40 mg or a placebo once a day
Primary	VEGF-A+MCP-1-induced monocyte chemotaxis after 1-month treatment with atorvastatin 40 mg or a placebo once a day
Secondary	HGF+MCP-1-induced monocyte chemotaxis after 1-month treatment with atorvastatin 40 mg or a placebo once a day