Study of the Inflammatory Activity in Diabetic Patients With Stable Angina Treated With Simvastatin and Ezetimibe - Full Text View

Sponsor:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00474123

Purpose

This study is designed to test the hypothesis that the association of ezetimibe to simvastatin will enhance the anti-inflammatory properties observed with simvastatin alone in high-risk cardiovascular patients such as diabetic patients with stable coronary syndromes. Inflammation will be denoted by measuring the following markers: C-reactive protein (CRP), interleukin (IL)-6, IL-1, monocyte chemoattractant protein (MCP)-1, soluble intercellular adhesion molecule (sICAM)-1 and oxidized LDL-C (oxLDL). Progenitor endothelial cells are also determined.

Diabetic patients with known, stable coronary artery disease and LDL-C levels between 90-160 mg/dl will be randomized to two lipid-lowering regimens: simvastatin 80 mg or ezetimibe/simvastatin 10/20 mg, for six weeks. Blood samples are collected before and after lipid-lowering treatment for determination of inflammatory markers. Throughout the study, all participants are encouraged to follow diet, perform physical activity and to take other medications.

Condition	Intervention
Diabetes Stable Angina	Drug: simvastatin or ezetimibe/simvastatin, 6 weeks

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Study of the Inflammatory Activity in Diabetic Patients With Stable Angina Treated With Simvastatin and Ezetimibe

Resource links provided by NLM:

MedlinePlus related topics: Angina Diabetes

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Inflammation will be denoted by measuring the following markers: CRP, interleukins, MCP-1, sICAM-1 and oxLDL. Progenitor endothelial cells are also determined. [ Time Frame: 6 weeks ]

Estimated Enrollment:	80
Study Start Date:	January 2006
Estimated Study Completion Date:	May 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diabetic patients
Stable angina
LDL cholesterol 70-160 mg/dl

Exclusion Criteria:

Renal failure
Age>80
Simvastatin current treatment>20mg
Hepatic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474123

Contacts

Contact: Carlos V Serrano, phd

55-11-30695058 ext 55-11

carlos.serrano@incor.usp.br

Locations

Brazil
Heart Institute (InCor) HCFMUSP	Recruiting
Sao Paulo, Brazil, 05403-000
Contact: Carlos V Serrano, phd 55-11-30695058 ext 11-55 carlos.serrano@incor.usp.br
Principal Investigator: CARLOS V SERRANO, PHD

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator:

CARLOS V SERRANO, PHD

Heart Institute (InCor) HCFMUSP

More Information

No publications provided

Study ID Numbers:	893/05
Study First Received:	May 15, 2007
Last Updated:	May 15, 2007
ClinicalTrials.gov Identifier:	NCT00474123 History of Changes
Health Authority:	Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:

diabetes
angina
atherosclerosis

simvastatin
ezetimibe
inflammation

Additional relevant MeSH terms:

Antimetabolites
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Myocardial Ischemia
Antilipemic Agents
Angina Pectoris
Vascular Diseases
Enzyme Inhibitors

Pain
Ezetimibe
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Chest Pain
Signs and Symptoms
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010