Leipzig Immediate Versus Early and Late PercutaneouS Coronary Intervention triAl in NSTEMI - LIPSIA-NSTEMI TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 10
- 主要终点
- peak creatine kinase- MB level
研究概览
简要总结
In non-ST-elevation the optimal time of percutaneous coronary intervention (PCI) is unclear.
Some studies showed benefit of very early PCI, some others early PCI between 12-48 hours and others even showed a benefit of a selective invasive approach only in case of recurrence of symptoms or a positive stress test.
The optimal timing of intervention is still matter of debate as a result of a randomized clinical trial.
详细描述
In this randomized, controlled, open-label clinical trial we compare a very early cardiac catheterization (< 2,5 hours after randomization) similar to ST-elevation myocardial infarction treatment, versus an early invasive approach (within 2-48 hours after randomization) versus a selective invasive approach in patients with non-ST-elevation myocardial infarction.
All patients are treated with heparin, ASA, Clopidogrel loading dose (600 mg) with subsequent 75 mg/d and tirofiban for 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical symptoms:
- •Instable angina pectoris:
- •Angina at rest < 24 hours
- •new onset worsening angina within the last weeks with angina at very low threshold < 24 h
- •Troponin T:
- •Troponin T-elevation ≥ 0,03 μg/l
- •Informed consent
排除标准
- •Age < 18 years
- •Age > 90 years
- •Hemodynamic instability
- •Cardiogenic shock
- •Warfarin therapy
- •Contraindications for GpIIb/IIIa-inhibitors
- •life expectancy < 6 months
- •known high bleeding risk
- •Other reasons for Troponin-elevation: Myocarditis, secondary after hypertensive crisis, cardiac decompensation
- •No informed consent
结局指标
主要结局
peak creatine kinase- MB level
时间窗: 5 days
次要结局
- Major bleeding complications (GUSTO definition)(30 days)
- Composite: death, re-myocardial infarction, recurrent unstable angina(6 months)