Effect of Low-dose Intracoronary Reteplase During Primary Percutaneous Coronary Intervention on Myocardial Infarct Size in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Myocardial infarct size
研究概览
简要总结
OBJECTIVE: To determine whether a therapeutic strategy involving low-dose intracoronary fibrinolytic therapy with reteplase infused after coronary reperfusion will reduce the myocardial infarction size.
DESIGN, SETTING, AND PARTICIPANTS: 306 patients presenting at 15 hospitals in China within 12 hours of acute ST-segment elevation myocardial infarction (STEMI) due to a proximal-mid-vessel occlusion of left anterior descending (LAD) coronary artery occlusion will be randomized in a 1:1:1 dose-ranging trial design. Patients will be followed up to 1 month.
INTERVENTIONS: Participants will be randomly assigned to treatment with placebo (n = 102), reteplase 9mg (n = 102), or reteplase 18mg (n = 102) by manual infusion over 2 minutes after reperfusion of the infarct-related coronary artery and before stent implant.
MAIN OUTCOMES AND MEASURES The primary outcomewas the myocardial infarct size (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI) conducted from days 2 through 7 after enrollment.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute STEMI with persistent ST-segment elevation or recent left bundle-branch block with a symptom onset to reperfusion time of 12 hours or less.
- •Angiographic criteria included a proximal-mid coronary artery occlusion (TIMI coronary flow grade 0 or 1) or, impaired coronary flow (TIMI flow grade 2, slow but complete filling) in the presence of definite angiographic evidence of large thrombus (TIMI grade ≥2) in left anterior descending (LAD) coronary artery.
排除标准
- •Rescue PCI after thrombolytic therapy.
- •Need for emergency coronary artery bypass grafting.
- •Presence of cardiogenic shock.
- •Life expectancy of < 6 months.
- •Inability to provide informed consent.
- •Contraindications for the use of thrombolysis, including active internal bleeding, history of intracranial haemorrhage or ischaemic stroke within 6 months, recent major surgery or trauma, severe uncontrolled hypertension, thrombocytopenia and severe liver or kidney failure.
研究组 & 干预措施
placebo
intracoronary infusion with saline
干预措施: Normal Saline (Drug)
reteplase 9mg
intracoronary infusion with reteplase 9mg
干预措施: Reteplase Injection 9mg (Drug)
reteplase 18mg
intracoronary infusion with reteplase 18mg
干预措施: Reteplase Injection 18mg (Drug)
结局指标
主要结局
Myocardial infarct size
时间窗: from days 2 through 7 after enrollment
Myocardial infarct size (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI)
次要结局
- TIMI flow grade(0-1 hour at the end of PCI)
- Amount of microvascular obstruction(from days 2 through 7 after enrollment)
- ST-segment resolution(60 minutes after reperfusion)
- CKMB level(immediately before reperfusion (0 hours) and then again at 2 hours and at 24 hours)
- Left ventricular ejection fraction(1 and 30 days after PCI)
- Incidence of major adverse cardiac events (MACE)(30 days after PCI)
- Myocardial Blush Grade(0-1 hour at the end of PCI)
- TIMI corrected frame count(0-1 hour at the end of PCI)
研究者
Ge Junbo
Director, Dept. of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China
Fudan University