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Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00819403
Recruitment Status : Completed
First Posted : January 9, 2009
Results First Posted : December 18, 2014
Last Update Posted : January 14, 2020
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Michael Miller, University of Maryland, Baltimore

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: simvastatin Drug: ezetimibe/simvastatin Phase 4

Detailed Description:
  1. 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.
  2. 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.
  3. To determine whether the addition of ezetimibe will yield extra protection beyond lipid modulation in the reduction of inflammation and platelet activation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : January 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
Other Name: vytorin

Primary Outcome Measures :
  1. Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression [ Time Frame: 6 weeks ]
    Measured using whole blood flow cytometry

Secondary Outcome Measures :
  1. Biomarkers of Inflammation [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Men and women greater than or equal to 21 years of age
  2. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00819403

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United States, Maryland
VA Maryland Health Care System
Baltimore, Maryland, United States, 21201
University of Maryland Medical Center
Baltimore, Maryland, United States, 21202
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
University of Maryland, Baltimore
Merck Sharp & Dohme Corp.
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Principal Investigator: MICHAEL MILLER, MD University of Maryland, College Park
Study Director: VICTOR L. Serebruany, MD, PhD President, HeartDrug Research LLC
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Responsible Party: Michael Miller, Dr., University of Maryland, Baltimore Identifier: NCT00819403    
Other Study ID Numbers: HP-00040970
MSP-JV IISP #32031
First Posted: January 9, 2009    Key Record Dates
Results First Posted: December 18, 2014
Last Update Posted: January 14, 2020
Last Verified: January 2020
Keywords provided by Michael Miller, University of Maryland, Baltimore:
low hdl
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors