A Comparative study to evaluate the efficacy and safety of Bempedoic acid versus Ezetimibe in patients with Dyslipidemia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Achieving the target level of fasting LDL-C less than 70 mg/dl
研究概览
简要总结
Title : A Comparative study to evaluate the efficacy and safety of Bempedoic acid versus Ezetimibe in patients with Dyslipidemia
Background : Dyslipidemia is characterized by an elevation of serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), or triglycerides (TG) and reduced serum high-density lipoprotein cholesterol (HDL-C) concentration. Bempedoic acid is a nonstatin for hypercholesterolemia. BA is ATP-citrate lyase inhibitor. It reduces hepatic cholesterol synthesis,which lead to clearance of LDL particles from circulation. Ezetimibe is a non-statin lipid-lowering medication that works by inhibiting the absorption of dietary cholesterol in the small intestine.
MATERIAL AND METHODS: The study was conducted as a prospective, randomized, open-labeled trial at Era’s Lucknow Medical College and Hospital, with collaboration between the Department of Pharmacology and the Department of Medicine. A total of 106 patients participated, evenly distributed with 53 patients in each group. The study spanned a period of 18 months, during which patients with Atherosclerotic Cardiovascular Disease (ASCVD) and uncontrolled levels of Low-Density Lipoprotein Cholesterol (LDL-C), despite receiving the maximum tolerated dose of statin, were enrolled from the medical outpatient department of ELMC&H in Lucknow
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Stable atherosclerotic cardiovascular disease Uncontrolled LDL cholesterol level (fasting more than 70 mg/dl) on maximally tolerated dose of statin.(Atrovastatin 80 mg OD, Rosuvastatin 40 mg OD).
排除标准
- •Age less than 18 yr BMI more or equal 40 kg/m sq.
- •Triglyceride levels more or equal to 500 mg/dl History of statin intolerance History of cardiac event in last 12 weeks Pregnant and Lactating women.
结局指标
主要结局
Achieving the target level of fasting LDL-C less than 70 mg/dl
时间窗: 0 week 6 weeks 12 weeks
次要结局
- The study shall further examine the adverse drug reaction caused by Bempedoic acid 180 mg and Ezetimibe 10 mg in patients of dyslipidemia.(0,6,12th weeks)
研究者
Afzal Noor
Eras Lucknow Medical College