NCT01977755已完成2 期
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess Clinical Efficacy and Safety of Danegaptide in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
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
- 591
- 试验地点
- 1
- 主要终点
- Myocardial Salvage Index
研究概览
简要总结
This study explores the potential cardioprotective properties of danegaptide when administered to patients with ST-Segment elevation myocardial infarction.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •ST-segment elevation myocardial infarction
- •Acute onset of chest pain of < 12 hours duration
排除标准
- •Pregnancy
- •Known prior Myocardial Infarction in same area as present STEMI, known hypertrophic or dilated cardiomyopathy, or prior hospital admission for heart failure
- •Contraindication for cardiac MRI
- •Inability to understand information or provide informed consent
研究组 & 干预措施
danegapetide high dose
Active Comparator
7,5 mg bolus injection, followed by 22,5 mg infused over 6 hours
干预措施: danegaptide (Drug)
danegaptide low dose
Active Comparator
2,5 mg bolus injection, followed by 7,5 mg infused over 6 hours
干预措施: danegaptide (Drug)
Placebo
Placebo Comparator
bolus injection, followed by infused over 6 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Myocardial Salvage Index
时间窗: 3 months
Myocardial Salvage Index as assessed by MRI and calculated as the difference between myocardial volume at risk and final infarct size in relation to myocardial volume at risk
次要结局
- Relative Infarct size, Absolute Infarct size, Left Ventricular Ejection Fraction (LVEF), microvascular obstruction and infarct haemorrhage as determined by MRI(3 months)
- Major Clinical Adverse Events including cardiac death, new or worsening heart failure and re-admission for heart failure(3 months)
- Degree of ST-resolution and fraction of patients with 70 % ST-resolution measured by ECG 60 minutes post Percutaneous Coronary Intervention procedure(60 minutes)
研究者
研究点 (1)
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