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临床试验/NCT00685464
NCT00685464已完成不适用

Intravenous vs. Intracoronary Use of Abciximab

University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 355 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
355
试验地点
1
主要终点
Death, TVR, bleeding, stroke

研究概览

简要总结

The aim of this study is to investigate wether intracoronary use of bolus Abciximab is superior to intravenous bolus in patients undergoing percutaneous coronary intervention.

详细描述

STEMI patients with indication for adjuvant therapy with GPI during pPCI, and who gave informed consent, were randomized, using sealed, opaque envelopes, to either IC or IV bolus (0.25 mg/kg body weight) followed by a 12-hour IV infusion of abciximab (0.125 μg/kg body weight per minute). IC bolus of abciximab was delivered via the PCI guiding catheter directly into the culprit artery, whereas IV bolus was given in a peripheral vein, both after filtering of the drug. The drug of use in our centre is Reo-Pro® manufactured by Eli Lilly, Denmark, who had no involvement, economically or scientifically, in the trial.

Inclusion criteria in the present analysis were STEMI (onset of chest pain ≤ 12 hours and ST-segment elevation in two contiguous leads of ≥ 2 mm in V1-V3 or ≥ 1 mm in other leads), age ≥ 18 years and indication for adjuvant therapy with abciximab (e.g. as bail-out in case of no-reflow, high thrombus burden, dissection, or type B2/C lesions) on the operator's discretion.

Exclusion criteria were known allergy to abciximab, ongoing bleeding, recent stroke, major surgery within 2 months, known bleeding disorder, or pregnancy.

All patients were pre-treated with oral Aspirin (300-500 mg) and Clopidogrel (300-600 mg) and 10,000 IU of unfractionated heparin given IV as a single-dose according to national guidelines for STEMI patients referred for pPCI. Patients were discharged with life-long Aspirin in a dose of 75 mg/day and Clopidogrel for 12 months in a dose of 75 mg/day.

In relation to PCI the following data were recorded: infarct localization on ECG and coronary angiography, number of diseased vessels, TIMI flow before and after PCI, lesion type (A, B, C), and type and number of stents implanted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Usually inclusion criteria for Abciximab, that is:
  • Adjunct to PCI for the prevention of cardiac ischemic complications:
  • In patients undergoing PCI
  • In patients with UA not responding to conventional medical therapy when PCI is planned within 24 hours

排除标准

  • Usually exclusion criteria for Abciximab, that is:
  • Active internal bleeding, recent (within 6 weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance
  • History of cerebrovascular accident (CVA) within 2 years, or CVA with a significant residual neurological deficit
  • Bleeding diathesis
  • Administration of oral anticoagulants within 7 days unless prothrombin time is less than or equal to 1.2 times control, thrombocytopenia (<100,000 cells/µL)
  • Recent (within 6 weeks) major surgery or trauma
  • Intracranial neoplasm
  • Arteriovenous malformation, or aneurysm
  • Severe uncontrolled hypertension
  • Presumed or documented history of vasculitis
  • Use of intravenous dextran before percutaneous coronary intervention, or intent to use it during intervention
  • Known hypersensitivity to any component of this product or to murine proteins.

研究组 & 干预措施

2

Active Comparator

Intravenous bolus Abciximab.

干预措施: Abciximab (Drug)

Abciximab

Active Comparator

Intracoronary bolus abciximab.

干预措施: Abciximab (Drug)

结局指标

主要结局

Death, TVR, bleeding, stroke

时间窗: 30 days and 1 year

次要结局

未报告次要终点

研究者

发起方
University Hospital, Gentofte, Copenhagen
申办方类型
Other

研究点 (1)

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