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临床试验/NCT03087539
NCT03087539Unknown2 期

Exploratory Phase II Clinical Trial to Evaluate the Efficacy and Safety of Clotinab® (Abciximab) in Acute Myocardial Infarction Patients: Multicenter, Randomized, Double Blind, Placebo-controlled and Parallel Group Trial

ISU Abxis Co., Ltd.1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
2 期
入组人数
146
试验地点
1
主要终点
Correlation between the Infarct size and MACE

研究概览

简要总结

Exploratory Phase II Clinical Trial to Evaluate the Efficacy and Safety of Clotinab® (Abciximab) in Acute Myocardial Infarction Patients: Multicenter, Randomized, Double-Blind, Placebo-controlled and Parallel Group Trial

详细描述

This study was an exploratory phase 2 of Clinical Trial to evaluate the efficacy and safety of Clotinab® (Abciximab) in the acute myocardial infarction patients and was designed as a multicenter, randomized, double-blinded, placebo-controlled and parallel group study. The objective of this phase 2 clinical trial is to evaluate correlation between infarct size and major adverse cardiac event (MACE) of acute myocardial infarction patient, prearranged for percutaneous coronary intervention(PCI), to measure possibility to use infarct size as a primary efficacy test variable in phase 3 for final confirmation of safety and efficacy.

Also to determine exploratively an average variance estimation of infarct size between study drug and placebo to confirm safety and efficacy of study drug, compared to placebo and to use the estimation for calculating sample size for phase III clinical trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlation between the Infarct size and MACE

时间窗: 18 months

To determine correlation between infarct size and MACE

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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