NCT00819403已完成4 期
The Effects of Ezetimibe/Simvastatin Versus Simvastatin Alone on Platelet and Inflammatory Biomarkers in Patients With the Metabolic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression
研究概览
简要总结
To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.
详细描述
- 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.
- 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.
- To determine whether the addition of ezetimibe will yield extra protection beyond lipid modulation in the reduction of inflammation and platelet activation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 < 40 mg/dL for men, and < 50 mg/dL for women
- •blood pressure > 130/85 mm Hg
- •fasting glucose > 100 mg/dL
排除标准
- •Patients will be excluded for a history of bleeding diathesis
- •drug or alcohol abuse
- •prothrombin time greater than 1.5 times control
- •platelet count < 100,000/mm3
- •hematocrit < 25%
- •creatinine > 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
研究组 & 干预措施
simvastatin
Active Comparator
Simvastatin 40 mg daily
干预措施: simvastatin (Drug)
simvastatin/ezetimibe
Active Comparator
Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
干预措施: ezetimibe/simvastatin (Drug)
结局指标
主要结局
Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression
时间窗: 6 weeks
Measured using whole blood flow cytometry
次要结局
- Biomarkers of Inflammation(6 weeks)
研究者
Michael Miller
Dr.
University of Maryland, Baltimore
研究点 (3)
Loading locations...
相似试验
已完成
3 期
Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578)Hyperlipoproteinemia Type IIAtherosclerosisHypercholesterolemiaNCT00552097Organon and Co720
已完成
3 期
A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)Coronary DiseaseNCT00551447Organon and Co616
已完成
4 期
Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 DiabetesDiabetes Mellitus Type 2HypercholesterolemiaNCT01384058University Hospital Freiburg41
已完成
4 期
The PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin StudyMetabolic SyndromeNCT00817843dr.Frank L.J. Visseren100
已完成
4 期
Ezetimibe and Statins on Postprandial Lipemia in Type 2 DiabetesPostprandial LipemiaType 2 DiabetesNCT00699023Federico II University13