CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 337
- 试验地点
- 25
- 主要终点
- TIMI 2/3 patency of the infarct-related artery immediately prior to PCI
研究概览
简要总结
Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted myocardium, which can be achieved by either thrombolytic therapy or primary PCI.
Primary PCI is facilitated if the flow in the target vessel is restored prior to the intervention. In addition the results of recent trials hint that clinical outcome is improved by a patent infarct-vessel before primary PCI. The CIPAMI-study analyses the effect of an early administration of Clopidogrel on the flow-rates in subjects who suffered an acute myocardial infarction. For this purpose they are divided into two groups, both receiving standard baseline treatment. The subjects of one group additionally receive 600mg of Clopidogrel, as early as possible, while the subjects in the second group receive standard therapy. In the second group Clopidogrel is not allowed before initial angiography.
In both groups the flow-rates before and after PCI are analysed and compared in order to evaluate the efficacy, feasibility, and safety of the administration of a high loading dose Clopidogrel in the very early phase of STEMI in the prehospital setting.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute STEMI <= 6 hrs.
- •Planned percutaneous coronary intervention
- •Age >= 18 years
- •Ability to understand the natures, scope, and possible consequences of the study / legal capacity
- •Informed consent
排除标准
- •Thrombolytic therapy within 24 hours before randomization
- •Effective oral or intravenous anticoagulation (INR>2, or PTT>2xcontrol)
- •Known hemorrhagic diathesis
- •Stroke or TIA within 3 months
- •Evidence of an active gastrointestinal or urogenital bleeding
- •Major surgery (including CABG) within 6 weeks
- •Contraindication to Clopidogrel
- •Severe renal or hepatic insufficiency
- •Contraindication to coronary angiography
- •Planned administration of a GP IIb/IIIa-Inhibitor before angiography
- •Pregnant or nursing (lactating) women
- •Women with childbearing potential
- •Patients currently (within the last 10 days) treated with clopidogrel or ticlopidine
- •Participation in another clinical or device trial within the previous 30 days
研究组 & 干预措施
1
Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy)
干预措施: Clopidogrel (Iscover/Plavix) (Drug)
结局指标
主要结局
TIMI 2/3 patency of the infarct-related artery immediately prior to PCI
时间窗: Assessment at primary PCI, asap after inclusion of the subject
次要结局
- Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge(Starting with inclusion of the subject until day 7)
- TIMI 3 patency before PCI(Assessment before primary PCI, asap after inclusion of the subject)
- TIMI 3 patency after PCI(Assessment at primary PCI, asap after inclusion of the subject)
- ST resolution immediately before angiography and 60-90 minutes after PCI(Assessment immediately before angiography until 90 minutes after PCI)
- Stroke (hemorrhagic, non-hemorrhagic)(Starting with inclusion of the subject until day 7)
- Severe bleeding complications according to the TIMI classification(Starting with inclusion of the subject until day 7)