Dose escalation trial of the efficacy, safety, and pharmacokinetics of a novel fibrinolytic agent, BB-10153, in patients with ST elevation MI: Results of the TIMI 31 trial

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• 作者：C. Michael Gibson ; Cafer Zorkun ; Peter Molhoek ; Krzysztof ?mudka ; Mark Greenberg ; Hiltrud Mueller ; Jan Wesdorp ; Hans Louwerenburg ; Alan Niederman and Jaap Westenburg ; et al.
• 关键词：Fibrinolytic ; ST elevation myocardial infarction ; TIMI Flow Grade ; TIMI frame count
• 刊名：Journal of Thrombosis and Thrombolysis
• 出版年：2006
• 出版时间：August 2006
• 年：2006
• 卷：22
• 期：1
• 页码：13-21
• 全文大小：295 KB
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Cardiology
  Hematology
  
• 出版者：Springer Netherlands
• ISSN：1573-742X

文摘

Background: Currently available fibrinolytic agents are limited by their ability to restore normal blood flow in only half of patients, the risk of reocclusion, and the risk of intracranial hemorrhage. The genetically engineered agent BB-10153 is activated by thrombin, not plasminogen activator enzymes, which limits its activity to the site of thrombus which may in turn reduce the risk of systemic bleeding. BB-10153 also has a relatively long half-life of 3–4 hours, which may also limit the potential for early reocclusion [1, 2]. Methods: The study was a phase II, open-label, multi-center, dose escalation, single-dose administration study to determine the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of BB-10153 in ST segment elevation MI (STEMI). STEMI patients (n = 50) received a single dose of BB-10153 at one of six dose levels (1.0, 2.0, 3.0, 5.0, 7.5 and 10 mg/kg). The primary endpoint was TIMI flow grade (TFG) 3 at 60 minutes following the intravenous bolus of BB-10153.