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Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment

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ClinicalTrials.gov Identifier: NCT00819403
Recruitment Status : Completed
First Posted : January 9, 2009
Results First Posted : December 18, 2014
Last Update Posted : December 18, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Michael Miller, University of Maryland, College Park

Tracking Information
First Submitted Date  ICMJE January 7, 2009
First Posted Date  ICMJE January 9, 2009
Results First Submitted Date  ICMJE February 27, 2013
Results First Posted Date  ICMJE December 18, 2014
Last Update Posted Date December 18, 2014
Study Start Date  ICMJE January 2009
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
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 ]
Change History Complete list of historical versions of study NCT00819403 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
Biomarkers of Inflammation [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment
Official Title  ICMJE The Effects of Ezetimibe/Simvastatin Versus Simvastatin Alone on Platelet and Inflammatory Biomarkers in Patients With the Metabolic Syndrome
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
  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Drug: simvastatin
    Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
    Other Name: zocor
  • 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
Study Arms  ICMJE
  • Active Comparator: simvastatin
    Simvastatin 40 mg daily
    Intervention: Drug: simvastatin
  • Active Comparator: simvastatin/ezetimibe
    Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
    Intervention: Drug: ezetimibe/simvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2010)
15
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2009)
30
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00819403
Other Study ID Numbers  ICMJE HP-00040970
MSP-JV IISP #32031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Miller, University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, College Park
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: MICHAEL MILLER, MD University of Maryland, College Park
Study Director: VICTOR L. Serebruany, MD, PhD President, HeartDrug Research LLC
PRS Account University of Maryland, Baltimore
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP