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Tnkase (Tenecteplase) - Summary

 



TNKASE SUMMARY

Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using an established mammalian cell line (Chinese Hamster Ovary cells).

TNKase is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms.
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NEWS HIGHLIGHTS

Published Studies Related to Tnkase (Tenecteplase)

Bolus tenecteplase for right ventricle dysfunction in hemodynamically stable patients with pulmonary embolism. [2009.10.13]
INTRODUCTION: The clinical benefit of thrombolytic treatment over heparin in patients with pulmonary embolism without hemodynamic compromise remains controversial. In these patients bolus tenecteplase has the potential to provide an effective and safe thrombolysis... CONCLUSION: In hemodynamically stable patients with PE, treatment with single bolus tenecteplase is feasible at the same dosages used for acute myocardial infarction and is associated with reduction of RVD at 24hours. Whether this benefit is associated with an improved clinical outcome without excessive bleeding is currently explored in a large clinical trial.

Tenecteplase and tirofiban in ST-segment elevation acute myocardial infarction: results of a randomized trial. [2005.07]
BACKGROUND: The combination of older reduced-dose fibrinolytic agents and platelet glycoprotein IIb/IIIa inhibitors has shown modest improvements in reperfusion and more striking improvements in ST-segment resolution after acute myocardial infarction. We performed a multicenter dose-ranging study of reduced doses of a newer fibrinolytic (tenecteplase) combined with tirofiban, a glycoprotein IIb/IIIa inhibitor... CONCLUSIONS: Although combination therapies were not associated with increased reperfusion compared with full-dose tenecteplase alone, similar TIMI flow grades were achieved despite reductions in tenecteplase doses. ST-segment resolution was more rapid and complete with combination therapy versus full-dose tenecteplase, suggesting enhanced microcirculatory perfusion to the infarct zone in this dose-ranging trial.

International multicentre trial protocol to assess the efficacy and safety of tenecteplase during cardiopulmonary resuscitation in patients with out-of-hospital cardiac arrest: the Thrombolysis in Cardiac Arrest (TROICA) Study. [2005.05]
Prehospital cardiac arrest has been associated with a very poor prognosis.

Association between platelet receptor occupancy after eptifibatide (integrilin) therapy and patency, myocardial perfusion, and ST-segment resolution among patients with ST-segment-elevation myocardial infarction: an INTEGRITI (Integrilin and Tenecteplase in Acute Myocardial Infarction) substudy. [2004.08.10]
CONCLUSIONS: This study links restoration of epicardial flow, normal myocardial perfusion, and complete ST-segment resolution with higher levels of platelet glycoprotein IIb/IIIa receptor occupancy after therapy with eptifibatide administered with tenecteplase.

Comparison of rapidity of coronary recanalization in men with tenecteplase versus alteplase in acute myocardial infarction. [2004.06.15]
To determine whether tenecteplase (TNK-t-PA), a bioengineered variant of tissue-type plasminogen activator (t-PA) designed to accelerate thrombolysis, exhibits favorable properties compared with those of alteplase, 266 men were studied </=6 hours after the onset of symptoms and signs of acute myocardial infarction...

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Clinical Trials Related to Tnkase (Tenecteplase)

Trial to Compare the Efficacy and Safety of a Single Bolus of TNK-tPA (Tenecteplase, Metalyse®) With Accelerated Infusion of rt-PA (Alteplase, Actilyse®) in Asian Patients With Acute Myocardial Infarction [Completed]
The objective of this trial was to compare the efficacy and safety of a single bolus of TNK-tPA (tenecteplase, Metalyse®) compared with rt-PA (alteplase, Actilyse®) in Asian patients.

A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Access Catheters [Recruiting]
This is a Phase III, open-label, single-arm study that will be conducted at approximately 35 centers in the United States and Canada. Approximately 210 adult and pediatric subjects with dysfunctional CVA catheters will be enrolled in the study and treated with one or two doses of tenecteplase.

Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest. The TROICA Trial. [Terminated]

A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Access Catheters [Recruiting]
This is a Phase III, randomized, double-blind, placebo-controlled study that will be conducted at approximately 25 centers in the United States and Canada. Approximately 100 adult and pediatric subjects with dysfunctional CVA catheters will be randomly assigned in a 1: 1 ratio to receive an initial dose of either placebo (Arm A) or tenecteplase (Arm B).

A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters [Recruiting]
This is a Phase III, open-label study that will be conducted at approximately 60 centers in the United States and Canada. Approximately 225 subjects ≥ 16 years of age who require HD and have a dysfunctional HD catheter will be enrolled in the study.

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Page last updated: 2009-10-20

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