Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment - Full Text View

Sponsor:	University of Maryland
Collaborator:	Merck
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00819403

Purpose

To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.

Condition	Intervention	Phase
Metabolic Syndrome	Drug: simvastatin Drug: ezetimibe/simvastatin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	The Effects of Ezetimibe/Simvastatin Versus Simvastatin Alone on Platelet and Inflammatory Biomarkers in Patients With the Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Metabolic Syndrome

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:

To determine the ex vivo effects of treatment with Vytorin versus Zocor for 6 weeks on platelet alpha thrombin PAR-1 receptor expression. The flow cytometry measurements will be done by the central core lab in a blinded fashion. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

We will compare how treatment with Vytorin versus Zocor for 6 weeks will affect platelet activity, and inflammatory biomarkers as secondary endpoints for the study. [ Time Frame: 3 mo ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: simvastatin Simvastatin 40 mg daily	Drug: simvastatin Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. Other Name: zocor
Active Comparator: simvastatin/ezetimibe Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.	Drug: ezetimibe/simvastatin Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.

Detailed Description:

To assess the ex vivo effects of ezetimibe/simvastatin (E/S) (Vytorin 10/40mg) and simvastatin (S) (Zocor 40mg) on platelet and inflammation biomarkers in patients with documented metabolic syndrome.
To compare platelet-related effects including PAR-1 receptor inhibition of E/S with those of the established anti-platelet agents including aspirin, clopidogrel, intravenous and oral glycoprotein IIb/IIIa inhibitors.
To determine whether the addition of ezetimibe will yield extra protection beyond lipid modulation in the reduction of inflammation and platelet activation.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Men and women greater than or equal to 21 years of age
Diagnosis of metabolic syndrome. We defined the presence of metabolic syndrome based on the US National Cholesterol Education Program's Adult Treatment Panel III guidelines. Specifically, metabolic syndrome will be diagnosed and documented when 3 of the following 5 characteristics will be present:
- abdominal obesity, given as waist circumference for men > 102 cm, and for women > 88 cm
- triglycerides > 150 mg/dL
- HDL cholesterol < 40 mg/dL for men, and < 50 mg/dL for women
- blood pressure > 130/85 mm Hg
- fasting glucose > 100 mg/dL

Exclusion Criteria:

Patients will be excluded for a history of bleeding diathesis
drug or alcohol abuse
prothrombin time greater than 1.5 times control
platelet count < 100,000/mm3
hematocrit < 25%
creatinine > 4.0 mg/dl
surgery or angioplasty performed within 3 months or planned for the future
history of gastrointestinal or other bleeding
history of drug-induced disorders
trauma, cancer, rheumatic diseases, coronary artery disease or stroke
Patients participating in other investigational drug trials within one month of completion will be also excluded
Patients treated with intravenous platelet glycoprotein IIb/IIIa inhibitors or thienopyridines, within past 6 months
Patients treated with statins or aspirin within past four weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819403

Contacts

Contact: MICHAEL MILLER, MD	410 328-6299	mmiller@medicine.umaryland.edu
Contact: Rachel Knopp, BS	410-706-1692	rknopp@medicine.umaryland.edu

Locations

United States, Maryland
University of Maryland Medical Center	Recruiting
Baltimore, Maryland, United States, 21202
Contact: Michael Miller, MD 410-328-6299 mmiller@medicine.umaryland.edu
Contact: Abigail Roberts, BA 410-706-1693 aroberts@medicine.umaryland.edu
Principal Investigator: Michael Miller, MD
VA Maryland Health Care System	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Michael Miller, M.D. 410-328-6299 mmiller@medicine.umaryland.edu
Contact: Abigail Roberts, BA 410-706-1693 aroberts@medicine.umaryland.edu
Principal Investigator: Michael Miller, M.D.
Johns Hopkins Hospital	Recruiting
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

University of Maryland

Merck

Investigators

Principal Investigator:	MICHAEL MILLER, MD	University of Maryland
Study Director:	VICTOR L. Serebruany, MD, PhD	President, HeartDrug Research LLC

More Information

No publications provided

Responsible Party:	Michael Miller, MD, Director, Center for Preventive Cardiology, University of Maryland Medical Center, University of Maryland Medical Center
ClinicalTrials.gov Identifier:	NCT00819403 History of Changes
Other Study ID Numbers:	HP-00040970, MSP-JV IISP #32031
Study First Received:	January 7, 2009
Last Updated:	August 11, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Maryland:

triglycerides
hypertension
low hdl
obesity

Additional relevant MeSH terms:

Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Simvastatin
Ezetimibe
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012