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
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
- 否
入选标准
- •Patients with acute myocardial infarction having ST segment, 1 mm or above, from at least 2 consecutive segment.
- •Patients have a plan of Percutaneous Coronary Intervention (PCI)
排除标准
- •History of myocardial infarction
- •History of hypersensitivity in aspirin, heparin, or protein drugs
- •Bleeding disorders
- •Thrombocytopenia (<100,000unit/㎕)
- •Cardiogenic shock, chronic atrial fibrillation, and cancer
- •Patients with following criteria: Implanted pacemakers, defibrillators, intracranial metallic implants, pregnant, etc
- •Had a history of surgical operation within 4 weeks
- •Participated in other clinical trials within 2 months
研究组 & 干预措施
Placebo
0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours
干预措施: Placebo (Biological)
Clotinab (Abciximab)
0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours
干预措施: Abciximab (Biological)
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