Triple (Atorvastatin, Ezetimibe, and Bempedoic Acid) Versus Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in LDL cholesterol level
研究概览
简要总结
The goal of this clinical trial is to evaluate whether triple lipid-lowering therapy (atorvastatin, ezetimibe, and bempedoic acid) is more effective than dual therapy (atorvastatin and ezetimibe) in reducing LDL cholesterol levels in adults with acute coronary syndrome. It will also assess the safety of the treatment.
The main questions it aims to answer are:
- Does triple therapy result in greater reduction in LDL-C compared to dual therapy?
- What adverse effects occur in participants receiving triple therapy?
Researchers will compare triple therapy to dual therapy to determine its effectiveness in lowering LDL-C levels.
Participants will:
- Receive either dual or triple lipid-lowering therapy for 3 months
- Attend regular follow-up visits for clinical assessment and laboratory testing
- Undergo lipid profile evaluation at baseline and at the end of the study
详细描述
Acute coronary syndrome (ACS) is a major cause of morbidity and mortality worldwide and is associated with a high risk of recurrent cardiovascular events. Aggressive lipid-lowering therapy, particularly reduction of low-density lipoprotein cholesterol (LDL-C), plays a central role in secondary prevention. Although high-intensity statins are the cornerstone of therapy, many patients fail to achieve target LDL-C levels, necessitating the addition of other lipid-lowering agents.
Ezetimibe, a cholesterol absorption inhibitor, has been shown to further reduce LDL-C levels when combined with statins. Bempedoic acid, a newer lipid-lowering agent that inhibits ATP citrate lyase, offers an additional mechanism to reduce cholesterol synthesis and may provide incremental benefits when added to standard therapy. However, limited evidence exists regarding the combined use of atorvastatin, ezetimibe, and bempedoic acid in patients with ACS.
This randomized controlled trial aims to compare the efficacy and safety of triple lipid-lowering therapy (atorvastatin, ezetimibe, and bempedoic acid) versus dual therapy (atorvastatin and ezetimibe) in patients with ACS. Eligible participants will be randomly assigned in a 1:1 ratio to receive either dual therapy or triple therapy. The intervention period will be three months.
The primary outcome of the study is the change in LDL-C levels from baseline to 3 months. Secondary outcomes include percentage reduction in LDL-C, changes in total cholesterol levels, proportion of patients achieving target LDL-C levels (<70 mg/dL), and incidence of adverse drug reactions.
Participants will undergo baseline clinical evaluation and laboratory investigations, including lipid profile assessment. Follow-up assessments will be conducted during the study period to monitor treatment response and safety. At the end of the study period, lipid levels and clinical outcomes will be reassessed and compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study in which both participants and investigators will be aware of the assigned treatment groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be older than 18 years, male or female.
- •Diagnosis of ACS (Acute Coronary Syndrome) is confirmed when hospitalized.
- •Eligible for high-intensity statin therapy (atorvastatin)
- •Patients can provide written informed consent.
- •Patients will be eager to cooperate with study drugs and follow-up visits.
排除标准
- •Intolerance or hypersensitivity to study drugs.
- •Liver or ALT/AST greater than three times the upper normal.
- •Renal dysfunction: estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m².
- •Gout with frequent bouts or severe hyperuricemia.
- •Pregnancy/lactation
研究组 & 干预措施
Triple Therapy Group
Participants will receive triple lipid-lowering therapy consisting of atorvastatin, ezetimibe, and bempedoic acid for a duration of 3 months.
干预措施: Bempedoic Acid 180 MG Oral Tablet (Drug)
Dual Therapy Group
Participants will receive dual lipid-lowering therapy consisting of atorvastatin and ezetimibe for a duration of 6 weeks.
干预措施: Atorvastatin 40 Mg Oral Tablet (Drug)
Triple Therapy Group
Participants will receive triple lipid-lowering therapy consisting of atorvastatin, ezetimibe, and bempedoic acid for a duration of 3 months.
干预措施: Atorvastatin 40 Mg Oral Tablet (Drug)
Dual Therapy Group
Participants will receive dual lipid-lowering therapy consisting of atorvastatin and ezetimibe for a duration of 6 weeks.
干预措施: Ezetimibe 10 mg (Drug)
Triple Therapy Group
Participants will receive triple lipid-lowering therapy consisting of atorvastatin, ezetimibe, and bempedoic acid for a duration of 3 months.
干预措施: Ezetimibe 10 mg (Drug)
结局指标
主要结局
Change in LDL cholesterol level
时间窗: Baseline to 3 months
Change in low-density lipoprotein cholesterol (LDL-C) measured in mg/dL from baseline to 3 months after initiation of therapy.
次要结局
- Incidence of adverse drug reactions(3 months)
研究者
Usman Sajid
Principal Investigator
Punjab Institute of Cardology