Cholesterol and Pharmacogenetic Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Total Cholesterol
研究概览
简要总结
The overall objective of the CAP study was to determine genetic influences on efficacy of simvastatin treatment with regard to LDL cholesterol reduction and changes in other markers of cardiovascular disease risk.
详细描述
Despite widespread use of statin therapy for reducing risk of cardiovascular disease risk, there is considerable inter-individual variation in statin efficacy, and it would be desirable to identify markers that would be predictive of the magnitude of beneficial response. The effect of statin most strongly associated with improved clinical outcomes is reduction in LDL cholesterol. The CAP study was a six week non-randomized, open label study of simvastatin 40 mg/day in a group of 335 African-American and 609 Caucasian volunteer subjects. Measurements of plasma lipids and lipoproteins, as well as other markers of cardiovascular disease risk, were obtained at the screening and entry visits, and after four and six weeks of simvastatin treatment. Both baseline measurements and changes in response to simvastatin therapy are being used to test for associations with genetic polymorphisms. Significant findings are being replicated in other study cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 30 years of age
- •Total Cholesterol between 160 to 400 mg/dl
- •> 3 grandparents of African-American descent or > 3 grandparents of Caucasian descent
- •serum triglycerides < 400 mg/dl
- •fasting glucose < 126 mg/dl
排除标准
- •Use of lipid-lowering medication
- •Use of over-the-counter products containing sterol or stanol esters or fish oil
- •Recent or planned change in dietary intake or weight change of more than 4.5 kg
- •Use of corticosteroids, immunosuppressive drugs or drugs affecting the CYP3A4 system
- •Known liver disease or elevated transaminase levels
- •Elevated creatine phosphokinase levels > 10 times upper limits of normal
- •Uncontrolled blood pressure, or diabetes mellitus
- •Abnormal renal or thyroid function
- •Current alcohol or drug abuse
- •Major illness in the preceding three months
- •Pregnancy
- •Know intolerance to statins
- •Racial ancestry other than African-American or Caucasian
结局指标
主要结局
Total Cholesterol
时间窗: -2, 0, 4, 6 weeks
LDL Cholesterol
时间窗: -2, 0, 4, 6 weeks
HDL Cholesterol
时间窗: -2, 0, 4, 6 weeks
Triglycerides
时间窗: -2, 0, 4, 6 weeks
C-reactive protein
时间窗: -2, 0, 4, 6 weeks
次要结局
- Total Cholesterol/HDL Cholesterol(-2, 0, 4, 6 weeks)
- Apolipoprotein B(-2, 0, 4, 6 weeks)
- Apolipoprotein AI(-2, 0, 4, 6 weeks)
- Apolipoprotein CIII(-2, 0, 4, 6 weeks)
- LDL Peak Particle size(-2, 0, 4, 6 weeks)
- LDL Subfractions(-2, 0, 4, 6 weeks)