TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,732
- 试验地点
- 96
- 主要终点
- The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure
研究概览
简要总结
This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.
详细描述
The hypothesis for TOTAL is that the routine use of manual aspiration thrombectomy with an aspiration catheter (Export®) with PCI compared to PCI alone will reduce the incidence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure (HF) at 180 days in patients with STEMI undergoing primary PCI.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with:
- •Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND
- •Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
- •Referred for primary PCI
- •Randomized within 12 hours of symptoms onset and prior to diagnostic angiography
- •Informed consent
排除标准
- •Age ≤ 18 years
- •Prior coronary artery bypass surgery (CABG)
- •Life expectancy less than six months due to non-cardiac condition
- •Treatment with fibrinolytic therapy for qualifying index STEMI event
结局指标
主要结局
The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure
时间窗: up to 180 days
次要结局
- Stroke(up to 30 days)
- Cardiovascular Mortality(up to 180 days)
- Key Secondary Efficacy Outcome: The first occurence of cardiovascular death, myocardial infarction, cardiogenic shock, new or worsening NYHA class IV heart failure, stent thrombosis and target vessel revascularization(up to 180 days)
- Key Net Benefit Outcome: The first occurence of CV death, MI, stroke, cardiogenic shock or new or worsening NHYA Class IV heart failure(up to 1 year)
研究者
Dr. Sanjit S. Jolly
MD MSc, FRCP(C), Interventional Cardiologist, Assistant Professor
Population Health Research Institute