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临床试验/NCT06966674
NCT06966674招募中不适用

Assessment of No-Reflow in Patients With STEMI After Intracoronary Tirofiban After Opening of the Track

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Blood stream

研究概览

简要总结

This study aims to assess the no-reflow in patients with STEMI after intracoronary glycoprotein IIb/IIIa inhibitors after opening of track in thrombus.

详细描述

ST-segment-elevation myocardial infarction (STEMI) is most commonly caused by rupture or erosion of an atherosclerotic plaque, resulting in acute occlusion of the coronary artery, and the preferred reperfusion strategy is primary percutaneous coronary intervention (PCI).

The no-reflow phenomenon is one of the most common causes of adverse cardiovascular events in patients STEMI.

In recent years, mechanical or pharmacological treatment strategies including adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPI) have been proposed in patients with STEMI.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old.
  • Both sexes.
  • Patients with STEMI. ST-segment elevated myocardial infarction is defined as typical chest pain >30 minutes with ST-segment elevation of >1 mm in at least 2 consecutive leads on the electrocardiogram or new-onset left bundle brunch block.

排除标准

  • Treatment with thrombolytic drugs in the previous 24 hours.
  • Known malignancy.
  • Thrombocytopenia.
  • End-stage liver disease.
  • Cardiogenic shock.
  • Renal failure with glomerular filtration<30 ml/min.
  • Contraindication for the use of tirofiban.

研究组 & 干预措施

Intracoronary tirofiban group

Experimental

Patients will receive intracoronary tirofiban (Aggrastat®) (25 mg/kg)

干预措施: Intracoronary tirofiban (Drug)

Control group

Placebo Comparator

Patients will receive intracoronary saline 0.9% solution as a control group.

干预措施: Saline 0.9% (Drug)

结局指标

主要结局

Blood stream

时间窗: After treatment (Up to 15 minutes)

Blood stream in coronary artery before and after treatment, including Thrombolysis in Myocardial Infarction (TIMI) flow grade in IRAs, coronary blood flow will be calculated with TIMI frame count method.

次要结局

  • Incidence of major adverse cardiac events(After treatment (Up to 30 days))

研究者

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

Mohammed Ali Mohammed Hammad

Lecturer of Cardiology, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Kafrelsheikh University

研究点 (1)

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