Back to resultsSimvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
simvastatin
ezetimibe/simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring triglycerides, hypertension, low hdl, obesity
Eligibility 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
Sites / Locations
- VA Maryland Health Care System
- University of Maryland Medical Center
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
simvastatin
simvastatin/ezetimibe
Arm Description
Simvastatin 40 mg daily
Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
Outcomes
Primary Outcome Measures
Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression
Measured using whole blood flow cytometry
Secondary Outcome Measures
Biomarkers of Inflammation
Full Information
NCT ID
NCT00819403
First Posted
January 7, 2009
Last Updated
January 10, 2020
Sponsor
University of Maryland, Baltimore
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00819403
Brief Title
Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment
Official Title
The Effects of Ezetimibe/Simvastatin Versus Simvastatin Alone on Platelet and Inflammatory Biomarkers in Patients With the Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
triglycerides, hypertension, low hdl, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
simvastatin
Arm Type
Active Comparator
Arm Description
Simvastatin 40 mg daily
Arm Title
simvastatin/ezetimibe
Arm Type
Active Comparator
Arm Description
Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
Intervention Type
Drug
Intervention Name(s)
simvastatin
Other Intervention Name(s)
zocor
Intervention Description
Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
Intervention Type
Drug
Intervention Name(s)
ezetimibe/simvastatin
Other Intervention Name(s)
vytorin
Intervention Description
Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
Primary Outcome Measure Information:
Title
Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression
Description
Measured using whole blood flow cytometry
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Biomarkers of Inflammation
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MICHAEL MILLER, MD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
VICTOR L. Serebruany, MD, PhD
Organizational Affiliation
President, HeartDrug Research LLC
Official's Role
Study Director
Facility Information:
Facility Name
VA Maryland Health Care System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
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Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment
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