A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 593
- 试验地点
- 38
- 主要终点
- Global Infarct Size
研究概览
简要总结
This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult participants presenting with acute STEMI (ST segment elevation myocardial infarction).
The study will enrol participants presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also undergo an index and an end of study CTA.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
In this study, the participant and sponsor staff will be blinded. Sites will be trained to keep the investigator blinded. However, due to the acute nature of the study, members of the research team and, possibly, the investigator may be unblinded.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation
- •Planned for primary PCI (percutaneous coronary intervention)
- •Men and women without child-bearing potential aged 30-80 years of age
- •Capable and willing to provide informed consent.
- •Capable of completing study visits
排除标准
- •Fibrinolytic administration for index event
- •Known prior MI or prior coronary artery bypass graft (CABG) surgery
- •Known pre-existing cardiomyopathy
- •History of anaphylaxis
- •Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo cardiomyopathy)
结局指标
主要结局
Global Infarct Size
时间窗: 70 to 84 days post Day 1 dose
Global infarct size expressed as a percentage of left ventricle (LV) mass measured on delayed-enhanced cardiovascular magnetic resonance (CMR) imaging in 10-12 weeks post myocardial infarction (MI) is reported.
次要结局
- Left Ventricular Ejection Fraction (LVEF)(70 to 84 days post Day 1 dose)
- Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI)(70 to 84 days post Day 1 dose)
- Left Ventricular End-diastolic and End-systolic Volume(70 to 84 days post Day 1 dose)
- Left Ventricular End-diastolic and End-systolic Volume Index(70 to 84 days post Day 1 dose)
- Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B(Day 1 dose (48 to 72 hours post Dose 1) through 70 to 84 days post Day 1 dose)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(Day 1 through Day 195 post Day 1 dose)
- Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012(Predose on Day 1, Day 17, Day 31, 70 to 84 days, and on Day 195 post Day 1 dose)
- Left Ventricular Mass by Late Gadolinium Enhancement (LGE)(70 to 84 days post Day 1 dose)
- Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass)(Pre- and post-dose on Days 1, 3, 17, and 31)