Phase II clinical study of TY-51924 in patients with acute myocardial infarction - Proof of concept study -

TOA EIYO LTD.0 个研究点目标入组 100 人开始时间: 待定

适应症

试验速览

阶段: 2 期
发起方: TOA EIYO LTD.
入组人数: 100
主要终点: Myocardial salvage index

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
干预模型: Multicenter, randomized, double-blind, placebo-controlled, parallel-assignment

入排标准

年龄范围: 20age old over 至 79age old under（—）
性别: All

入选标准

•Admission to hospital within 6 hrs of the onset of symptoms
•Chest pain lasting for >= 30 min
•ST-segment elevation of >= 0.2 mV in 2 or more contiguous precordial leads (V1-V4) on standard 12-lead electrocardiogram
•TIMI flow grade 0/1 in left anterior descending artery (LAD) on diagnostic coronary angiography (CAG)
•Written informed consent

排除标准

•Prior documented old myocardial infarction (MI) or a clinical history of definite MI
•Left main trunk (LMT) stenosis >50%
•Total occlusion of left circumflex artery (LCX) or right coronary artery (RCA)
•Left bundle-branch block
•Suspected acute aortic dissection
•Cardiac arrest or cardiogenic shock
•Thrombolytic therapy or coronary artery bypass grafting (CABG)
•Hepatic and/or renal dysfunction
•History of allergy or drug hypersensitivity
•Pregnancy or nursing mothers or childbearing women

结局指标

主要结局

Myocardial salvage index

时间窗: 3-5 days after PCI

Myocardial salvage index at 3-5 days after percutaneous coronary intervention (PCI)

Incidence of adverse events and side effects

时间窗: 7 days after PCI

Incidence of adverse events and side effects for 7 days after PCI

次要结局

未报告次要终点

研究者

发起方

TOA EIYO LTD.

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