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临床试验/NCT03991143
NCT03991143已完成2 期

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

Athera Biotechnologies AB1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2019年3月29日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Phosphorylcholine human monoclonal antibody (ATH3G10)

干预措施: ATH3G10 (Drug)

Placebo

Placebo Comparator

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))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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