A study to compare the effect of Bempedoic acid added to statin therapy vs statin monotherapy in lowering the remnant cholesterol in established Atherosclerotic cardiovascular disease(ASCVD) patients: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- To establish the effect of bempedoic acid in lowering the remnant cholesterol
研究概览
简要总结
STUDY JUSTIFICATION: • Recent studies have shown that elevated levels of remnant cholesterol was associated with an increased risk of ASCVD
• Bempedoic acid has been shown effectively lower ldl levels not controlled with high intensity statins alone.
• This interventional study is being done to establish the effect of bempedoic acid in lowering the remant cholesterol level
STUDY DESIGN- An open label randomized controlled trial
SAMPLE SIZE:88 (44 in each group)
METHODOLOGY : • Select patients fitting the inclusion criteria
• Measure the lipid profile and calculate the remnant cholesterol levels(remnant cholesterol= total cholesterol – [LDL cholesterol+HDL cholesterol] at baseline.
• Patients were randomized 1:1 to treatment with bempedoic acid (180 mg) once daily for 12 weeks in the intervention group
• Remnant cholesterol in measured at day 0 and day 90
• Apolipoprotein B is measured at day 0 and at day 90
• HsCRP measured at day 0 and day 90
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 established ASCVD on statins 2)LDL cholesterol of more than 55 mg/dl.
排除标准
- •Patients without established ASCVD 2)Patients not on statins 3)Lactating breastfeeding mothers 4)LDL cholesterol of less than 55 mg/dl 5)patients already on bempedoic acid 6)Patients on other anti-lipidemic drugs other than statins.
结局指标
主要结局
To establish the effect of bempedoic acid in lowering the remnant cholesterol
时间窗: DAY 0 AND DAY 90
次要结局
- To determine the effect of bempedoic acid on other components of lipid profile,Apolipoprotein B and HsCRP(DAY 0 AND DAY 90)
研究者
Dr Ashwin J Dhas K S
SRM Medical College Hospital and Research Center