Phase 4 N=15 Randomized Triple-blind Treatment

Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment

Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00819403 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression — 35.4; 34.5; 23.6; 22.5 ng/dl

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: simvastatin (Drug); ezetimibe/simvastatin (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Maryland, Baltimore
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression	35.4; 34.5; 23.6; 22.5	—
SECONDARY Biomarkers of Inflammation	3.51; 3.57; 1.24; 1.33	—

Summary

To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.

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 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00819403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.