Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment

Metabolic Syndrome Clinical Trial

Official title:

The Effects of Ezetimibe/Simvastatin Versus Simvastatin Alone on Platelet and Inflammatory Biomarkers in Patients With the Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819403
• Other study ID #: HP-00040970
• Secondary ID: MSP-JV IISP #320
• Status: Completed
• Phase: Phase 4
• Start date: January 2009
• Est. completion date: November 2011

Study information

• Verified date: January 2020
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Drug:
• simvastatin
Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
• ezetimibe/simvastatin
Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	VA Maryland Health Care System	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression	Measured using whole blood flow cytometry	6 weeks
Secondary	Biomarkers of Inflammation		6 weeks