NEWS HIGHLIGHTS
Published Studies Related to Cathflo Activase (Alteplase)
Facilitated PCI by combination fibrinolysis or upstream tirofiban in acute ST-segment elevation myocardial infarction: results of the Alteplase and Tirofiban in Acute Myocardial Infarction (ATAMI) trial. [2008.11.12]
CONCLUSIONS: Combination fibrinolysis before PCI leads to significantly higher TIMI flow rates of the infarct-related vessel without increase in 30-day mortality or in bleeding complications. This strategy needs to be further investigated in larger trials and could optimise acute myocardial infarction management even without 24-h service of catheter laboratories.
Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. [2008.09.25]
BACKGROUND: Intravenous thrombolysis with alteplase is the only approved treatment for acute ischemic stroke, but its efficacy and safety when administered more than 3 hours after the onset of symptoms have not been established. We tested the efficacy and safety of alteplase administered between 3 and 4.5 hours after the onset of a stroke... CONCLUSIONS: As compared with placebo, intravenous alteplase administered between 3 and 4.5 hours after the onset of symptoms significantly improved clinical outcomes in patients with acute ischemic stroke; alteplase was more frequently associated with symptomatic intracranial hemorrhage. (ClinicalTrials.gov number, NCT00153036.) 2008 Massachusetts Medical Society
Comparison of alteplase and heparin in maintaining the patency of paediatric central venous haemodialysis lines: a randomised controlled trial. [2007.06]
OBJECTIVES: To determine whether the tissue plasminogen activator, alteplase, is more effective than heparin in preventing blood clots developing in children's haemodialysis central lines between dialysis sessions... CONCLUSION: Alteplase is significantly more effective than heparin in preventing clot formation in central haemodialysis lines. This reduces morbidity and improves preservation of central venous access. It is more expensive, though relatively economic if packaged into syringes and stored frozen until needed, but reduces the costs of unblocking or replacing clotted lines.
Short and long alteplase dwells in dysfunctional hemodialysis catheters. [2005.04]
BACKGROUND: Hemodialysis catheter dysfunction (CD) is the inability to attain adequate blood pump speeds (BPS) and is attributed to thrombus or catheter malposition; alteplase (TPA) is often given in a variety of dwell times to treat CD. The purpose of this study was to determine if TPA dwell time affects short- or long-term catheter patency rates... CONCLUSION: This study demonstrates that although patency for the next HD run can be achieved with either short or long TPA dwell, neither is reliable in terms of long-term patency. Strategies that employ TPA for CD are temporary and allow a 2-week window during which more definitive therapies for HD access should be sought.
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...
Clinical Trials Related to Cathflo Activase (Alteplase)
Cathflo Activase Pediatric Study [Completed]
This was a Phase IV, open-label, single-arm, multicenter trial that was to be conducted at
~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional
CVADs (including catheters with valves, multiple lumens, umbilical catheters, and implanted
ports) were to be treated with up to two serially instilled doses of Cathflo Activase.
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III [Recruiting]
The overall objective of this Phase III clinical trial is to obtain information from a
population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of
current clinical practice and national demographics of ICH regarding the benefit (or lack
thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS).
This application requests funding for five years to initiate a Phase III randomized
clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage.
The investigators propose to compare extraventricular drainage (EVD) use plus recombinant
tissue plasminogen activator (rt-PA, Cathflo® Activase® Genentech, Inc., San Francisco, CA)
with EVD+ placebo in the management and treatment of subjects with small intracerebral
hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and
obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
Safety and Efficacy of Tissue Plasminogen Activator (tPA) in Neonates and Infants [Recruiting]
Phase II Clinical Trial on Treatment of Intraventricular Hemorrhage [Recruiting]
The specific objective of this trial is to determine the lowest dose possible with the best
pharmacokinetic and safety profile and it's ability to remove a blood clot from the
ventricular system.
MIS+rtPA for ICH Evacuation [Recruiting]
The purpose of this trial is to determine the safety of using a combination of minimally
invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The
procedure is to use image-based surgery (MRI or CT) to provide catheter access to ICH for
the intervention, which is a one-time clot aspiration followed by instillation of rt-PA over
72 hours. We propose to test if this intervention facilitates more rapid and complete
recovery of function and decreased mortality from this condition compared to conventional
medical management without subjecting the patient to craniotomy. The specific objective of
this trial is to test the safety of this intervention and assess its ability to remove blood
clot from brain tissue.
|
