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临床试验/NCT01109134
NCT01109134已完成3 期

Prospective Randomized Controlled Clinical Study to Compare Tirofiban Intracoronary Bolus-Only vs Intravenous Bolus Plus Infusion in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Kosuyolu Heart Hospital0 个研究点目标入组 49 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
49
主要终点
Indices of microvascular perfusion

研究概览

简要总结

The aim of this randomized trial is to compare the efficacy of high dose tirofiban administered as either an intracoronary bolus alone or as an intravenous bolus followed by a maintenance infusion with respect to microvascular perfusion and long term left ventricular infarct size, volumes and function.

详细描述

Primary percutaneous coronary intervention (PCI) is currently the treatment of choice for patients with acute ST elevation myocardial infarction (STEMI). Nevertheless, despite restoration of normal epicardial flow, myocardial perfusion remains impaired in approximately half of patients and is associated with a poor prognosis. A variety of invasive and non-invasive techniques have been proposed to evaluate microvascular perfusion and several invasive hemodynamic measures have been closely associated with microvascular damage.In order to improve microvascular perfusion after primary PCI, a variety of treatment strategies have been developed, such as adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPIs). Although current ACC/AHA guidelines recommend that small molecule GPIs should be administered as a bolus followed by 18 hours of continuous infusion, changes in clinical practice may obviate the need for a maintenance infusion in current practice.

We hypothesized that when tirofiban is administered via intracoronary route, a bolus-only strategy may even be superior to intravenous bolus plus infusion strategy in maintaining myocardial perfusion. In order to evaluate microvascular function, we used a guidewire tipped with pressure and temperature sensors and measured the coronary hemodynamic parameters, as the index of microvascular resistance and coronary flow reserve, measures which have been closely associated with microvascular damage. In order to increase the predictive value of these indices, we performed these measurements four to five days after MI, because it has been shown that the extent of microvascular dysfunction changes, particularly within first 48 hours after reperfusion and stabilizes between 2 days and 1 week after perfusion

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
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Typical ongoing ischemic chest pain for longer than 30 minutes
  • ST segment elevation of 0,1 mV or greater in at least two contiguous leads or a new left bundle branch block on the initial ECG.

排除标准

  • Cardiogenic shock and / or clinical instability
  • previous STEMI
  • Malignant life threatening diseases
  • Presence of an additional lesion causing more than 50% narrowing distal to the culprit lesion
  • Contraindications to aspirin, clopidogrel, or heparin
  • inability to give informed consent.

研究组 & 干预措施

Tirofiban intracoronary bolus-only

Experimental

Tirofiban bolus administered via intracoronary route at the time of primary PCI with no additional peri/postprocedural maintenance infusion

干预措施: tirofiban intracoronary bolus-only (Drug)

Tirofiban intravenous bolus+infusion

Active Comparator

Tirofiban bolus administered intravenously before PCI, followed by periprocedural maintenance infusion

干预措施: tirofiban intravenous bolus plus infusion (Drug)

结局指标

主要结局

Indices of microvascular perfusion

时间窗: Post-PCI day 4 to 5

Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve

次要结局

  • ST segment resolution(post-PCI 90. minute)
  • corrected TIMI frame count(immediately after PCI, post-PCI day 4 to 5)
  • Myocardial Blush Grade(immediately after PCI, post-PCI day 4 to 5)
  • Scintigraphic infarct size(6th month)
  • Changes in left ventricular volume(Post-PCI day 3- 6th month)
  • Composite of major adverse cardiovascular events(6 month)

研究者

发起方
Kosuyolu Heart Hospital
申办方类型
Other

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