NCT00538317已完成4 期
Comparison of Administration of Tirofiban in the Ambulance or in the Cathlab in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- TIMI 2-3 flow on first coronary artery opacification
研究概览
简要总结
In patients with acute myocardial infarction who are managed in the prehospital setting, and who will treated with primary angioplasty, we evaluate the benefit of an early administration of tirofiban, a powerful GPIIbIIIa inhibitors. Patients are randomised to early administration in the ambulance or administration in the cathlab. The primary endpoint is TIMI 2-3 flow in the first coronary opacification of the culprit artery.
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
- •Age > 18 years
- •Information given to the patient and consent obtained
- •Thoracic pain or symptoms of infarction
- •Symptoms < 12 hours
- •ST deviation identified by electrocardiography (ECG) in at least 2 contiguous leads
- •Transfer time to angioplasty room evaluated by the coordinating doctor as less than 90 minutes (from ECG diagnosis to arrival in angioplasty room)
- •Exclusion criteria
- •Physiological or pathological conditions not compatible with a revascularisation procedure (in the acute phase of myocardial infarction (MI)
- •Administration of fibrinolytics or another antiGPIIBIIIa in the previous seven days
- •Contraindications to aspirin or tirofiban or heparin
- •Diagnosed severe kidney failure (dialysis, creatinin > 350µmol/l
- •Pregnancy
- •Time for transfer to the angioplasty room evaluated by coordinating doctor as more than 90 minutes
- •Subject participating in another trial
- •Subject with high hemorrhagic risk.
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
tirofiban bolus + perfusion started at the site of caring
干预措施: tirofiban (Drug)
2
Active Comparator
tirofiban bolus + perfusion started at the beginning of coronarography (usual use of tirofiban)
干预措施: tirofiban (Drug)
结局指标
主要结局
TIMI 2-3 flow on first coronary artery opacification
时间窗: start of coronarography
次要结局
- Protocol déviations of Tirofiban administration (no bolus, bolus decreasing or increasing of +/- 10% from expected value, dose perfusion decreasing or increasing of 1 ml/h from expected value, time perfusion > 24h or < 18h(During tirofiban administration)
- TIMI 3, TIMI 2 and TIMI 1-0 flow frequency in responsible artery before and after angioplasty(before and after angioplasty)
- left ventricular ejection fraction value(during angioplasty)
- CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty)(during 24h after angioplasty)
- reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%)(after angioplasty)
- Outcome of following Serious Adverse Events: anginal recurrence, infarct recurrence, urgent revascularization, serious heart failure and hospital mortality(During hospitalization)
研究者
研究点 (1)
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