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Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Michael Miller, University of Maryland Identifier:
First received: January 7, 2009
Last updated: December 10, 2014
Last verified: December 2014
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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Michael Miller, University of Maryland:

Primary Outcome Measures:
  • 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:
  • Biomarkers of Inflammation [ Time Frame: 6 weeks ]

Enrollment: 15
Study Start Date: January 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (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 ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
Other Name: vytorin

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.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00819403

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
Merck Sharp & Dohme Corp.
Principal Investigator: MICHAEL MILLER, MD University of Maryland
Study Director: VICTOR L. Serebruany, MD, PhD President, HeartDrug Research LLC
  More Information

Responsible Party: Michael Miller, Dr., University of Maryland Identifier: NCT00819403     History of Changes
Other Study ID Numbers: HP-00040970
MSP-JV IISP #32031
Study First Received: January 7, 2009
Results First Received: February 27, 2013
Last Updated: December 10, 2014

Keywords provided by Michael Miller, University of Maryland:
low hdl

Additional relevant MeSH terms:
Metabolic Syndrome X
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 processed this record on September 21, 2017