Comparison of Intensive Lipid-Lowering Therapy With a Statin-Ezetimibe Combination (Without Aspirin) vs. Statin Monotherapy (With Aspirin) In Asymptomatic Patient With Coronary Artery Calcification
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 7,435
- 试验地点
- 1
- 主要终点
- Event rate of a major adverse cardiovascular events
研究概览
简要总结
A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification
详细描述
Coronary artery calcification is a well-established marker of subclinical atherosclerosis that effectively identifies high-risk individuals for cardiovascular events, even in asymptomatic patients. However, the optimal intensity of preventive interventions-particularly regarding the balance between efficacy and safety-remains unclear in asymptomatic patients with significant coronary calcification.
While aspirin has traditionally been used for the primary prevention of cardiovascular events, recent evidence suggests that its routine use in asymptomatic individuals may carry greater bleeding risks than cardiovascular benefits. In contrast, intensive lipid-lowering therapy with statins and ezetimibe has proven effective in reducing LDL-C levels and preventing cardiovascular events by slowing atherosclerotic progression and stabilizing plaques.
This study aims to evaluate whether intensive lipid-lowering therapy using a statin-ezetimibe combination (without aspirin) is non-inferior to statin monotherapy (with aspirin) in reducing cardiovascular events among patients with significant coronary artery calcification. By comparing these two strategies, we seek to establish whether more aggressive lipid management might obviate the need for aspirin in these intermediate- to high-risk yet asymptomatic patients.
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
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intensive lipid-lowering therapy without aspirin
In this group, intensive lipid-lowering therapy is performed without aspirin using pitavastatin 4 mg/ezetimibe 10 mg, targeting patients with coronary artery calcification (Agatston score ≥100) who require primary prevention and do not have physiologically significant coronary artery disease.
◦ Intervention Medications: Pitavastatin 4 mg/ezetimibe 10 mg (aspirin excluded)
干预措施: Pitavastatin 4mg and ezetimibe 10mg, taken once daily (Drug)
Statin Monotherapy with Aspirin
IIn this group, moderate-intensity lipid-lowering therapy is administered using pitavastatin 2 mg and aspirin for patients with coronary artery calcification (Agatston score ≥100) who require primary prevention and do not have physiologically significant coronary artery disease.
◦ Intervention Medications: Pitavastatin 2 mg and aspirin (Based on the clinician's judgment, the statin dosage may be increased to pitavastatin 4 mg depending on the LDL response, and if there are adverse effects associated with aspirin, it can be replaced with clopidogrel.)
干预措施: Pitavastatin 2 mg with aspirin 100 mg, taken once daily. (Drug)
结局指标
主要结局
Event rate of a major adverse cardiovascular events
时间窗: 48months
Death from any cause, myocardial infarction, stroke, urgent coronary revascularization, resuscitated cardiac arrest, or unstable angina related hospitalization
次要结局
- Event rate of a all cause death(48months)
- Event rate of a cardiovascular death(48months)
- Event rate of a spontaneous myocardial infarction(48months)
- Event rate of a stroke(48months)
- Event rate of a urgent coronary revascularization(48months)
- Event rate of a Resuscitated cardiac arrest(48months)
- Event rate of a unstable angina related hospitalization(48months)
- Event rate of a composite of hard outcomes (all cause death, myocardial infarction and ischemic stroke)(48months)
- Event rate of a Clinically relevant bleeding (Bleeding Academic Research Consortium definition ≥ type 2)(48months)
- Changes of Lipid profile(48months)
- Treatment-emergent Serious Adverse Events resulting in Study Drug Discontinuation(48months)
研究者
Seung-Whan Lee, M.D., Ph.D.
Principal Investigator
Asan Medical Center