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临床试验/IRCT201105126463N1
IRCT201105126463N1已完成3 期

Study of the effect of early bolus dose of tirofiban in emergency department on early TIMI flow 3 of the patients with myocardial infarction undergoing primary PCI

Tehran University of Medical Sciences0 个研究点目标入组 140 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
140

研究概览

简要总结

Effect of Early Treatment With Tirofiban on Initial TIMI Grade 3 Flow of Patients With ST Elevation Myocardial Infarction. Salarifar M, Mousavi M, Yousefpour N, Nematipour E, Kassaian SE, Poorhosseini H, Hajizeinali A, Alidoosti M, Aghajani H, Nozari Y, Amirzadegan A, Bozorgi A, Genab Y. Abstract Background: Before primary percutaneous coronary intervention (PCI) in patients with ST elevation myocardial infarction (STEMI), it is not clear whether a routine early administration of glycoprotein IIb/IIIa inhibitors in the emergency ward is beneficial or their administration in selected cases in the catheterization laboratory. Objectives: The present randomized clinical trial sought to investigate whether an earlier administration of Tirofiban could exert any impact on TIMI grade 3 flows and ST resolution in the electrocardiography of patients with STEMI before primary PCI. Materials and Methods: Patients with STEMI within twelve hours of symptom commencement were included if primary PCI was planned to be performed within ninety minutes of admission and excluded if they had contraindications for Tirofiban. Seventy patients were randomized to receive 25 µg/kg of bolus Tirofiban early in the emergency ward (the early Tirofiban group) in three minutes and 70 did not receive Tirofiban (the control group). The primary endpoint of the study was a Thrombolysis in Myocardial Infarction (TIMI) grade 3 flows on the initial angiogram. The study is registered as IRCT201105126463N1 in: www.irct.ir. Results: The study population had a mean age of 57.17 ± 10.09 years and included 79.3 % males. TIMI grade 3 flow was seen in 15 (21.4 %) patients of the Tirofiban group and 7 (10 %) of the control group (P = 0.06, odds ratio = 0.407, and 95 % confidence interval = 0.155-1.072). Complete ST resolution was seen in 30 (42.9 %) patients of the Tirofiban group and 34 (48.6 %) of the control group (P = 0.5). Conclusion: Although TIMI grade 3 flows trended to be higher in the patients who received early Tirofiban in the emergency ward, the difference did not constitute statistical significance and possible benefits, therefore, require further clarification. Iran Red Cres Med J. 2014 January; 16(1): e9641. DOI: 10.5812/ircmj.9641

研究设计

研究类型
Interventional

入排标准

年龄范围
no limit 至 75 years(—)
性别
All

入选标准

  • Acute myocardial infarction patient with ST segment elevation or new left bundle branch block in 12 hours of onset of symptoms and are candidate for primary PCI within 90 minutes of presentations to the emergency department

排除标准

  • Stroke or TIA within the past 30 days or any history of hemorrhagic stroke, well known intra cranial disease (neoplasm or aneurysm), any active bleeding or bleeding history in past 30 days, uncontrolled HTN at registry time (SBP>180, DBP>110), Major operation or trauma in recent 6 weeks, platlete count less than 100000 or bleeding conditions, Coagulation disorders (INR>1.5), Severe hepatic failure, Administration of any fibrinolytic treatment 24 hours from randomization, Renal failure (Cr>205mg/dl or GFR <30), age more than 75 years old

研究者

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