EVOLVE-MI: A Pragmatic Randomized Multicenter Trial of EVOLocumab Administered Very Early to Reduce the Risk of Cardiovascular Events in Patients Hospitalized With Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 6,019
- 试验地点
- 119
- 主要终点
- Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death
研究概览
简要总结
The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]).
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease
排除标准
- •Participants requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening
- •Participants with elevated biomarkers of myocardial injury due to secondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm, decompensated heart failure, uncontrolled hypertension, stress induced cardiomyopathy)
研究组 & 干预措施
Evolocumab + Routine Lipid Management
Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
干预措施: Routine Lipid Management (Drug)
Routine Lipid Management
Participants will receive routine lipid management per standard of care (SoC).
干预措施: Routine Lipid Management (Drug)
Evolocumab + Routine Lipid Management
Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
干预措施: Evolocumab (Drug)
结局指标
主要结局
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death
时间窗: From Baseline to End of Study (Approximately 3.5 Years)
次要结局
- Total Arterial Revascularization Procedures(From Baseline to End of Study (Approximately 3.5 Years))
- Total Ischemic Strokes(From Baseline to End of Study (Approximately 3.5 Years))
- Percentage Change From Baseline in LDL-C(From Baseline to Week 52)
- Time to All-Cause Death(From Baseline to End of Study (Approximately 3.5 Years))
- Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death(From Baseline to End of Study (Approximately 3.5 Years))
- Time to the First Occurrence of the Composite of Myocardial Infarction, Ischemic Stroke, any Arterial Revascularization Procedure, and All-Cause Death(From Baseline to End of Study (Approximately 3.5 Years))
- Total Myocardial Infarctions Events(From Baseline to End of Study (Approximately 3.5 Years))
- Time to Cardiovascular Death(From Baseline to End of Study (Approximately 3.5 Years))
- Total Ischemia-driven Coronary Revascularization Procedures(From Baseline to End of Study (Approximately 3.5 Years))