Activase® (Alteplase) is a tissue plasminogen activator produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids.
Acute Myocardial Infarction
Activase® (Alteplase) is indicated for use in the management of acute myocardial infarction in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure, and the reduction of mortality associated with AMI. Treatment should be initiated as soon as possible after the onset of AMI symptoms (see CLINICAL PHARMACOLOGY).
Acute Ischemic Stroke
Activase® (Alteplase) is indicated for the management of acute ischemic stroke in adults for improving neurological recovery and reducing the incidence of disability. Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage (see CONTRAINDICATIONS).
Activase® (Alteplase) is indicated in the management of acute massive pulmonary embolism (PE) in adults:
For the lysis of acute pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments of the lungs.
For the lysis of pulmonary emboli accompanied by unstable hemodynamics, e.g., failure to maintain blood pressure without supportive measures.
The diagnosis should be confirmed by objective means, such as pulmonary angiography or noninvasive procedures such as lung scanning.
Published Studies Related to Activase (Alteplase)
Increased benefit of alteplase in patients with ischemic stroke and a high body
(PAIS) trial... CONCLUSION: Patients with ischemic stroke and a high body temperature may have a
The effects of alteplase 3 to 6 hours after stroke in the EPITHET-DEFUSE combined
dataset: post hoc case-control study. 
using coregistration techniques... CONCLUSIONS: The data provide further evidence that alteplase significantly
Statistical aspects of the TNK-S2B trial of tenecteplase versus alteplase in acute ischemic stroke: an efficient, dose-adaptive, seamless phase II/III design. [2011.08]
BACKGROUND: TNK-S2B, an innovative, randomized, seamless phase II/III trial of tenecteplase versus rt-PA for acute ischemic stroke, terminated for slow enrollment before regulatory approval of use of phase II patients in phase III. PURPOSE: (1) To review the trial design and comprehensive type I error rate simulations and (2) to discuss issues raised during regulatory review, to facilitate future approval of similar designs... CONCLUSIONS: (1) The design was innovative and efficient. Per protocol, type I error was well controlled for the co-primary phase III hypothesis tests, and experiment-wise. (2a) Time must be allowed for communications with regulatory reviewers from first design stages. (2b) Adequate type I error control must be demonstrated. (2c) Greater clarity is needed on (i) whether this includes demonstration of type I error control if the protocol is violated and (ii) whether simulations of type I error control are acceptable. (2d) Regulatory agency concerns that protocols for futility stopping may not be followed may be allayed by submitting interim analysis results to them as these analyses occur.
SYNTHESIS expansion: design of a nonprofit, pragmatic, randomized, controlled trial on the best fast-track endovascular treatment vs. standard intravenous alteplase for acute ischemic stroke. [2011.06]
Rationale Reperfusion in ischemic stroke can be pursued by either systemic intravenous thrombolysis or endovascular treatment. However, systemic intravenous thrombolysis with alteplase within 4.5 h of symptom onset in selected patients is the only medication of proven efficacy... Secondary: neurological deficit seven-days after thrombolysis and the safety of the procedure on the basis of events reported within seven-days following thrombolysis - symptomatic cerebral hemorrhage, fatal and nonfatal stroke, death from any cause, neurological deterioration.
Statistical aspects of the TNK-S2B trial of tenecteplase versus alteplase in
acute ischemic stroke: an efficient, dose-adaptive, seamless phase II/III design. 
facilitate future approval of similar designs... CONCLUSIONS: (1) The design was innovative and efficient. Per protocol, type I
Clinical Trials Related to Activase (Alteplase)
Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas [Completed]
Alteplase for Blood Flow Restoration in Hemodialysis Catheters [Terminated]
We are investigating a new way of administering alteplase to remove clots from hemodialysis
catheters. Currently, alteplase is left to dwell inside the catheter between dialysis
treatments to dissolve the clot and restore blood flow through the catheter. We have
developed a new way to administer alteplase by advancing it to the tip of the catheter at
regular 10 minute intervals. We hypothesize that our new "push" protocol will dissolve
clots in hemodialysis catheters better and faster than the current dwell method.
Prolonged Hemodialysis Catheter Survival With Copolymer Coating and Rt-PA [Recruiting]
Surface thrombogenicity of standard double lumen catheters (stDLC) and surface modified
film-coated domain structured double lumen catheters (fcDLC) consisting of a novel reactive
polyurethane copolymer coating showed that in vitro measured surface thrombogenicity was
reduced in the modified catheter compared with standard catheter. The clinical investigation
revealed that both number of days before catheter removal according to clinical requirements
and number of treatments per catheter were significantly higher with the modified catheter
as compared with the standard catheter.
Recombinant tissue plasminogen activator (rt-PA) has been used primarily to treat catheter
thrombosis. The relatively high cost of rt-PA and its theoretical potential to cause
bleeding, as well as the morbidity and mortality associated with catheter malfunction and
infection, justify the need for more definitive evidence of the efficacy of rt-PA as a
No study aims to evaluate the impact of rt-PA locking in long-term Hemodialysis (HD)
uncuffed catheters survival.
Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke [Completed]
The primary goal of this trial is to determine if individuals with acute ischemic stroke
treated with a medium dose of IV rt-PA plus IV eptifibatide started within 3 hours of
symptom onset are more likely to have a better outcome than individuals treated with
standard IV rt-PA alone.
Interventional Management of Stroke (IMS) III Trial [Terminated]
The purpose of this study is to compare two different treatment approaches to recanalization
started within 3 hours of symptom onset—combined intravenous (IV) and endovascular therapy
and standard intravenous (IV) rt-PA alone.
Reports of Suspected Activase (Alteplase) Side Effects
Chest Pain (32),
Cerebral Haemorrhage (28),
Brain Oedema (14),
Ventricular Tachycardia (11),
Haemorrhage Intracranial (10), more >>
Page last updated: 2014-11-30