跳至主要内容
临床试验/NCT02054000
NCT02054000已完成4 期

Effectiveness of Intracoronary Tirofiban on No-Reflow Phenomena in Patients With ST-Elevated Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2011年1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
入组人数
162
试验地点
1
主要终点
in-hospital mortality

研究概览

简要总结

The goal of this study was to evaluate the acute effect of intracoronary administration of tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary percutaneous coronary intervention (PCI).

详细描述

The no-reflow phenomenon is one of the most common causes of adverse cardiovascular events in patients with ST-elevated myocardial infarction (STEMI). Re-canalization of infarct related arterial (IRA) flow related to better ventricular performance and lower mortality rate in patients with STEMI. In addition, no-reflow phenomena may limit the benefits of re-canalization of the IRA.

In recent years, many mechanical or pharmacological treatment strategies including adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPI) have been proposed in patients with STEMI. Although current guidelines recommend that small molecule GPI should be administered as an upstream bolus followed by a continuous infusion in patients with STEMI, changes in clinical practice may obviate the need for GPI dosage or routes in current practice. Previous studies have shown that intravenous and intracoronary administration of GPI improve the prognosis and significantly reduce mortality in patients with STEMI. Recently, the Ongoing Tirofiban in Myocardial infarction Evaluation-2 (ON-TIME 2) trial found that the use of tirofiban started during the pre-hospital phase as upstream therapy for primary percutaneous coronary intervention (PCI) and continued for up to 18 hours infusion after the procedure showed an improvement in the markers of reperfusion. Additionally, a reduction was demonstrated in the death in recurrent myocardial infarction in urgent target vessel revascularization and thrombotic bailout. However, in the current literature there are insufficient data regarding the role of intracoronary administration of GPI inhibitors in patients with STEMI who developed the no-reflow phenomenon. The goal of this study was to evaluate the acute effect of intracoronary administration of tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary PCI.

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
Double (Participant, Outcomes Assessor)

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

  • Patients with ST-elevated myocardial infarction who developed no-reflow phenomena

排除标准

  • Treatment with thrombolytic drugs in the previous 24 hours
  • Known malignancy
  • Pain to balloon time >6 hours
  • Uncontrolled hypertension (>180/110 mmHg)
  • Bleeding diathesis
  • Thrombocytopenia
  • End-stage liver disease
  • Cardiogenic shock
  • Renal failure
  • Life expectancy of less than 1 year
  • Contraindication for the use of tirofiban.

研究组 & 干预措施

Tirofiban group

Active Comparator

If thrombolysis in myocardial infarction flow <3 in spite of performed treatments, patients were considered as no-reflow and randomized to tirofiban or placebo group. Intracoronary tirofiban (25 µgr/kg) was administered via the guiding catheter to the infarct related artery

干预措施: Tirofiban (Drug)

Placebo group

Placebo Comparator

If thrombolysis in myocardial infarction flow <3 in spite of performed treatments, patients were considered as no-reflow and randomized to tirofiban or placebo group. Intracoronary serum physiologic as placebo was administered via the guiding catheter to the infarct related artery

干预措施: Placebo (Other)

结局指标

主要结局

in-hospital mortality

时间窗: up to 8 days

Non-fatal myocardial infarction

时间窗: up to 8 days

in-stent thrombosis

时间窗: up to 8 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmut Akpek

Medical doctor of Cardiology department

TC Erciyes University

研究点 (1)

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