Proportion of low responders to statin therapy and its predictors: A tertiary care hospital based prospective interventional study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 1. To estimate the Prevalence of low responders to Rosuvastatin in patients with atherosclerotic vascular disease and or at intermediate to high risk
研究概览
简要总结
This study is being conducted on patients with heart disease with high cholesterol levels and/or normal levels with high risk factors who have been prescribed Rosuvastatin 20 mg by treating cardiologist. As we know blockage of coronary arteries due to high cholesterol is the leading cause of death in India. This study will generate knowledge about variability in cholesterol lowering response of rosuvastatin in patients of heart disease. Suboptimal LDL cholesterol improvement is defined as less than 30 percent reduction in LDL levels and optimal LDL cholesterol improvement will be more than 30 percent reduction in LDL levels as compared to baseline levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with LDL more than or equal to 100 mg/dl with or without risk factors like smoking, obesity, hypertension, DM
- •Patients with LDL less than 100 mg/dl with risk factors.
排除标准
- •patients on other lipid lowering medications
- •patients not tolerating rosuvastatin
- •patients with active liver disease and myopathy 4.
结局指标
主要结局
1. To estimate the Prevalence of low responders to Rosuvastatin in patients with atherosclerotic vascular disease and or at intermediate to high risk
时间窗: 4 weeks
次要结局
- 1. To study the clinical determinants of low responders to Rosuvastatin therapy(4 weeks)
研究者
Dr Shamli Thakur
INDIRA GANDHI MEDICAL COLLEGE SHIMLA (H.P)