Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment
Information source: University of Maryland
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome
Intervention: simvastatin (Drug); ezetimibe/simvastatin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Maryland Official(s) and/or principal investigator(s):
MICHAEL MILLER, MD, Principal Investigator, Affiliation: University of Maryland
VICTOR L. Serebruany, MD, PhD, Study Director, Affiliation: President, HeartDrug Research LLC
Overall contact:
MICHAEL MILLER, MD, Phone: 410 328-6299, Email: mmiller@medicine.umaryland.edu
Summary
To determine whether the combination of ezetimibe and simvastatin improves biomarkers of
atherothromobosis compared to simvastatin alone in patients with the metabolic syndrome.
Clinical Details
Official title: The Effects of Ezetimibe/Simvastatin Versus Simvastatin Alone on Platelet and Inflammatory Biomarkers in Patients With the Metabolic Syndrome
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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 > 110 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
Locations and Contacts
MICHAEL MILLER, MD, Phone: 410 328-6299, Email: mmiller@medicine.umaryland.edu
University of Maryland Medical Center, Baltimore, Maryland 21202, United States; Recruiting
Michael Miller, MD, Phone: 410-328-6299, Email: mmiller@medicine.umaryland.edu
Beatrice Digen, BA, Phone: 410 328-6175, Email: bdigen@medicine.umaryland.edu
Michael Miller, MD, Principal Investigator
Additional Information
Starting date: January 2009
Ending date: June 2010
Last updated: February 13, 2009
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