2023-509268-26-00招募中4 期
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
Amgen Inc.15 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2024年4月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 15
- 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
To assess the effectiveness of treatment with evolocumab plus routine lipid management compared with 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 (NSTEMI and STEMI).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures; OR, subject’s legally authorized representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
- •Age ≥ 18 years (eg, if no upper age limit).
- •Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease.
排除标准
- •Patients requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening
- •Subject has known sensitivity to any of the products or components to be administered during dosing.
- •Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator’s knowledge.
- •History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- •Patients with elevated biomarkers of myocardial injury due to secondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm, decompensated heart failure, uncontrolled hypertension, stress induced cardiomyopathy).
- •History or evidence of clinically significant disease (eg, malignancy, respiratory, gastrointestinal, renal or psychiatric disease) or unstable disorder that, in the opinion of the investigator(s), Amgen physician or designee would pose a risk to the patient’s safety or interfere with the study assessments, procedures, completion, or result in a life expectancy of less than 1 year.
- •Previously received or receiving any therapy to inhibit PCSK9 in the following timeframe: • Evolocumab, alirocumab, or any other monoclonal antibody against PCSK9 within 3 months prior to screening. • Inclisiran within 6 months prior to screening.
- •Currently receiving treatment in another investigational (not approved for any use in the country the subject is to be randomized) device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- •Female subjects of childbearing potential unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 15 weeks after the last dose of investigational product.
- •Female subjects who are breastfeeding or who plan to breastfeed while on study through 15 weeks after the last dose of investigational product.
- •Female subjects planning to become pregnant while on study through 15 weeks after the last dose of investigational product.
- •Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test.
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.
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death.
次要结局
- Cardiovascular death
- All-cause death
- Total ischemia-driven coronary revascularization procedures
- Total ischemic strokes
- Percent LDL-C change from baseline to 12 weeks and 52 week in a subset of approximately 300 selected subjects.
- Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death.
- Time to the first occurrence of the composite of myocardial infarction, ischemic stroke, revascularization procedure, and all-cause death.
- Total myocardial infarctions
- Total arterial revascularization procedures
研究者
Thiago Oliveira
Scientific
Amgen Inc.
研究点 (15)
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