NCT00220571已完成3 期
Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction
Società Italiana di Cardiologia Invasiva168 个研究点 分布在 2 个国家目标入组 600 人开始时间: 2003年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 168
- 主要终点
- To compare 30 days incidence of the composite end-point of: mortality, reinfarction and refractory ischemia in the two arms of the study.
研究概览
简要总结
The aim of this study conducted in patients with high risk ST-segment elevation AMI admitted to hospitals with no PTCA facilities is to compare the effects on clinical outcome and cost-effectiveness of two reperfusion strategies:
- Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case of lack of reperfusion
- Elective referral for "facilitated" PTCA after early administration of Abciximab and half dose of Reteplase
详细描述
All patients with ST-segment elevation AMI admitted within 12 hours from symptoms onset will be screened to enter in this study. Data of patients with ST-segment elevation AMI within 12 hours from symptoms onset who do not meet the inclusion criteria or do not sign the informed consent form are entered into a dedicated registry.
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- ECG with ST-elevation (≥ 1mm in at least 2 ECG limb leads or ≥ 2 mm in 2 contiguous precordial leads) AMI within <12 hours from symptoms onset fulfilling 1 or more of the following criteria of "high risk":
- •Summation of ST-segment elevation or depression ≥ 15 mm in all 12 electrocardiographic leads or new onset complete left bundle branch block;
- •Previous myocardial infarction (Q- and non Q-wave);
- •Killip Class 2 or 3;
- •LV ejection fraction at transthoracic ultrasound < 40%.
排除标准
- •Inability to provide informed consent;
- •Age > 75 years
- •CABG or PCI procedure in past history involving the infarct-related artery;
- •Participation in another study with any investigational drug or device within the previous 30 days;
- •Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer);
- •Cardiogenic shock (hypotension with Systolic Blood Pressure (SBP) < 90 mmHg and tachycardia > 100 beats / min, not due to hypovolemia and requiring inotropic support or balloon counterpulsation);
- •Need for concomitant major surgery (e.g. valve surgery or resection of aortic or left ventricular aneurysm, carotid endarterectomy, abdominal aortic aneurysm surgery, congenital heart disease etc);
- •Severe hepatic disease;
- •Patients with acute or chronic renal impairment (serum creatinine > 2.0 mg % or 200 mg/l or creatinine clearance < 30 ml/min);
- •Transmural MI in different location within the previous week;
- •Previous administration of thrombolytics within 7 days;
- •Intolerance or contraindications to ASA or Clopidogrel;
- •Known leucopenia, defined as a leukocyte count of < 3.500 White Blood Cells (WBC)/ml
- •Known neutropenia, defined as < 1000 neutrophils / ml;
- •Known thrombocytopenia (< 100.000 platelets / ml );
- •Documented active peptic ulcer or upper gastrointestinal bleeding within the previous 6 months;
- •Previous hemorrhagic stroke;
- •Previous ischemic cerebrovascular event within 3 months;
- •Intracranial neoplasm;
- •Recent major surgery at risk of bleeding;
- •Episodes of uncontrolled hypertension (> 180/110 mmHg despite treatment) in past 2 years;
- •Administration of oral anticoagulants within the previous 7 days unless INR ≤ 1.2;
- •Severe recent trauma;
- •Known or possible pregnancy;
- •Absence of suitable vascular access (diffuse peripheral arterial disease);
- •Basal ECG changes which make identification of ST-segment elevation impossible (i.e.: ventricular activation from artificial pacemaker, etc.).
结局指标
主要结局
To compare 30 days incidence of the composite end-point of: mortality, reinfarction and refractory ischemia in the two arms of the study.
时间窗: 30 Day
次要结局
- Compare 1 year composite end-point of: mortality, reinfarction, refractory ischemia, hospital readmission because of heart failure in the two arms;(1 Year)
- Compare the resource use at 30 days and 1 year, including days in CCU, MICU or general ward, cost of catheterization and PTCA, drugs, ambulance service during index hospitalization and subsequent hospital admissions for reAMI(30 Day and 1 Year)
- Compare the incidence of in-hospital stroke and bleeding complications in the two arms.(30 Day)
研究者
研究点 (168)
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