A Phase IIa, Placebo-controlled, Double Blind, Randomised Multicentre Pilot Study to Investigate the Efficacy, Safety and Tolerability of the Monoclonal Antibody ATH3G10 in Patients With ST-elevation Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Left ventricular remodelling
研究概览
简要总结
Patients with ST-segment elevation myocardial infarction (STEMI) that have suffered a major anterior wall infarction or where coronary blood flow is less than normal in spite of successful percutaneous coronary intervention (PCI) have a poor prognosis. There are today no medical treatments that specifically reduce risk in these patients. The acute inflammatory reaction in conjunction with a STEMI and reperfusion by PCI determines the final size of the infarction and the signals leading to left ventricular remodelling.
This study is designed to assess the efficacy and safety of single intravenous injection with ATH3G10, a fully human IgG1 antibody against phosphorylcholine, in high-risk subjects with STEMI. ATH3G10 aims to reduce inflammation and thereby infarction size and remodeling.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction with ST elevation at the J-point in two contiguous leads
- •Start of PCI less than 4 hours after symptom onset.
排除标准
- •Cardiogenic chock, non-compensated acute heart failure and/or pulmonary edema.
- •Previous major vascular intervention within the last 4 weeks.
- •History of an infarct in the same artery that is currently affected.
- •Conditions contraindicating MRI
研究组 & 干预措施
ATH3G10
Phosphorylcholine human monoclonal antibody (ATH3G10)
干预措施: ATH3G10 (Drug)
Placebo
Placebo to ATH3G10, 0.9% sodium chloride
干预措施: Placebo (Drug)
结局指标
主要结局
Left ventricular remodelling
时间窗: From Visit2 (day 3) to visit 3 (day 90)
Change in Left Ventricular End-Diastolic Volume index (LV EDVi)
次要结局
- Myocardial Salvage index (MSi)(Visit 2 (day 3))
