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临床试验/NCT00133250
NCT00133250已完成4 期

Value of Abciximab in Patients With AMI Undergoing PCI After High Dose Clopidogrel Pretreatment (BRAVE 3)

Deutsches Herzzentrum Muenchen5 个研究点 分布在 2 个国家目标入组 800 人开始时间: 2003年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
800
试验地点
5
主要终点
Left ventricular infarct size calculated as the final perfusion defect at follow-up scintigraphic study

研究概览

简要总结

The purpose of this study is to assess whether abciximab is associated with additional benefit in patients with AMI treated with PCI after high dose clopidogrel loading.

详细描述

The goal of all reperfusion therapies in acute myocardial infarction (AMI) is an effective restoration of coronary blood flow and the reduction of infarct size. Recently, the researchers were able to achieve excellent results with primary stenting plus abciximab in terms of reduction of infarct size and improvement of clinical outcome in the STOPAMI trial. This strategy provided a clear benefit compared to fibrinolysis. On the basis of the data published in the last 2 years, hospitals without angioplasty facilities have now better possibilities to improve the results of primary treatment of patients with AMI by immediately referring these patients to highly experienced centers in coronary interventions. There is an increasing interest to assess the additional advantages of pharmacologic reperfusion approaches which are readily applicable in the time window between presentation and arrival at the catheterization room. Two studies have shown that the results of the PCI in patients with AMI pretreated with fibrinolysis may even be more unfavorable than those achieved with angioplasty alone. Glycoprotein (GP) IIb/IIIa blocker abciximab has been shown to improve the results of the primary PCI in AMI. However, no rapidly effective antiplatelets therapy was available at the time when the studies on the benefit of abciximab were performed. Recent studies have shown that a high, 600 mg loading dose of clopidogrel is significantly more rapidly acting and that maximal inhibition of platelet aggregation is achieved within 2 hours after administration. In the ISAR-REACT trial, a high loading dose of clopidogrel was well tolerated, associated with such a low frequency of procedural complications that the use of abciximab offered no clinically measurable benefit at 30 days.

Comparison:

Abciximab (bolus+infusion for 12h) versus Placebo (bolus+infusion for 12h) after pre-treatment with 600 mg clopidogrel.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting with ST-Elevation acute myocardial infarction within 24 hours from the onset of symptoms

排除标准

  • Age >80 years
  • Malignancies
  • Cardiogenic shock
  • Prolonged cardio-pulmonary resuscitation
  • Increased risk of bleeding
  • Relevant hematologic deviations (hemoglobin <100 g/L or hematocrit <34%, platelet count <100 x 10^9 /L or platelet count >600 x 10^9 /L)
  • Known allergy to the study medication
  • Pregnancy (present or suspected)

研究组 & 干预措施

A

Experimental

Abciximab

干预措施: Abciximab (Drug)

B

Placebo Comparator

Heparin Sodium

干预措施: Placebo Heparin Sodium (Other)

结局指标

主要结局

Left ventricular infarct size calculated as the final perfusion defect at follow-up scintigraphic study

时间窗: 5-7 days

次要结局

  • Clinical adverse events (death of any cause, reinfarction, stroke, urgent reinterventions, major and minor bleeding complications, thrombocytopenia <20 x 10^9 /L)(30 days)

研究者

发起方
Deutsches Herzzentrum Muenchen
申办方类型
Other

研究点 (5)

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