NCT04111289Unknown1 期
Effect of Upstream High Bolus Dose of Tirofiban in Primary PCI for the Patients With STEMI on Short Term Outcome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 150
- 主要终点
- Primary (main):
研究概览
简要总结
The goal of the study to investigate the impact of upstream HBD of Tirofiban on short outcome of STEMI patient.
详细描述
- Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST segment elevation myocardial infarction (STEMI).1 PPCI restores thrombolysis in myocardial infarction flow 3 (TIMI 3) in over 90% of patients. However ,there remains a small proportion of patients, who continue to exhibit overt impairment of myocardial reperfusion despite successful opening of infarct related epicardiual artery (IRA). This phenomenon is called no-reflow, which is largely because of severe microvascular obstruction (MVO).
- Belonging to the class of glycoprotein IIb/IIIa inhibitors (GPIs), tirofiban, can be useful in primary PCI for acute coronary syndrome (ACS).1,2The administration of tirofiban is an efficacious treatment option to reduce ischemic events in patients with The ACS and/or those undergoing PCI.2,3 In most guidelines, abciximab is recommended as the drug of first choice4 due to the finding that tirofiban is less effective than abciximab in platelet inhibition within 60 min of intravenous administration. However, some recent systemic reviews of randomized trials have not demonstrated obvious difference between smGPIs (eptifibatide or tirofiban) and abciximab in terms of angiographic, electrocardiographic, and clinical outcomes of patients undergoing primary PCI.5,6 Tirofiban may provide similar efficacy with an improved safety profile when compared with abciximab, particularly with a high-dose bolus regimen.7,8 In the new guideline, the recommended class of smGPIs has changed from IIb to IIa, but tirofiban remains with a pre-PCI indication of IIb, B.4 Although early treatment was associated with a significantly better TIMI flow and superior TIMI myocardial perfusion grades (TMPG) in some trials,9,10 no difference in clinical outcome was found between the 2 strategies in later study.11 One potential cost of administration of GPIs could be increased bleeding, although both major bleeding and minor bleeding rate are low in the tirofiban-treated patients..
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Acute STEMI patient within 12 hours of chest pain
排除标准
- •-previous infarction in the same infarct- related artery
- •Resistent cardiogenic shock
- •Known CKD with Cr cl less than 60 ml/min
- •Uncontrolled HTN more than 180/110 mmHg
- •Suspected aortic dissection
- •Traumatic or prolonged CPR
- •Severe trauma or major surgery within 3 month
- •Active peptic ulcer within past 3 month
- •Known history of coagulopathy
研究组 & 干预措施
Patient received upstream high bolus dose of tirofiban
Active Comparator
- After consenting for primary PCI ,the patient will be assigned to one arm ( either upstream high bolus dose IV before going to cath lab or selective downstream administration according to operator discretion )
- Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)
- Randomization will be performed by Microsoft Excel where random order will be generated for the study population
干预措施: -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion) (Drug)
Patients did not receive upstream high bolus dose of tirofiban
Active Comparator
Patient receive tirofiban downstream selectively according to operator discretion
干预措施: -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion) (Drug)
结局指标
主要结局
Primary (main):
时间窗: 40 days
Angiographic result (TIMI flow \& MB) after PPCI.
次要结局
未报告次要终点
研究者
Eman Qaood Mohammed
Principel investigator
Assiut University
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