LOG IN/REGISTER >
FORWARD TO A COLLEAGUE >
INDICATION/SAFETY INFORMATION >

Professional organizations support treatment with Activase (Alteplase)

Guidelines and consensus statements on the use of Activase (t-PA) in acute ischemic stroke

  • Practice guidelines and policy statements* by many professional organizations dedicated to improving outcomes support Activase (t-PA) use in eligible stroke patients within 3 hours of symptom onset
  • *
  • Note: Each of these guidelines or policy statements represents only one possible approach to the treatment of eligible acute ischemic stroke patients. Each healthcare practitioner and institution will need to exercise professional judgment in creating or adopting treatment protocols or guidelines, as well as in the treatment of each individual patient.

Genentech is neither affiliated with nor endorses any of the following organizations:

American Heart Association/American Stroke Association (AHA/ASA)

  • The 2007 American Heart Association/American Stroke Association Guidelines for the Early Management of Adults With Ischemic Stroke continues to give Activase (t-PA) its strongest recommendation (Class I, Level of Evidence A)1

Class I=conditions for which there is evidence for and/or general agreement that the procedure or treatment is useful and effective.

Level of Evidence A=data derived from multiple randomized clinical trials.

DOWNLOAD OR ORDER

American Academy of Neurology (AAN)

  • The AAN, in its Practice Advisory: Thrombolytic Therapy for Acute Ischemic Stroke, supports administration of Activase (t-PA) within FDA-approved labeling2

American College of Emergency Physicians (ACEP)

  • The ACEP, in its policy statement, Use of Intravenous t-PA for the Management of Acute Stroke in the Emergency Department, notes that IV t-PA may be efficacious in the management of acute ischemic stroke if used properly and when incorporating guidelines that were established by the National Institute of Neurological Disorders and Stroke3

Brain Attack Coalition (BAC)

  • The BAC,† in its 2005 consensus statement, Recommendations for Comprehensive Stroke Centers, recommends lytics as a component of a comprehensive stroke center (CSC)‡ (grade IIB)4§
  • †
  • The Brain Attack Coalition (BAC) is a multidisciplinary group of members from major professional organizations involved with the care of patients with stroke and cerebrovascular disease.
  • ‡
  • A comprehensive stroke center (CSC) is defined as a facility or system with the necessary personnel, infrastructure, expertise, and programs to diagnose and treat stroke patients who require a high intensity of medical and surgical care, specialized tests, or interventional therapies. Such patients include, but are not limited to, patients with ischemic stroke.
  • §
  • Supported by grade II evidence: data from randomized, controlled trial (RCT), but may have false positives or negatives; may not be FDA-approved, but therapy (Rx) is widely or commonly used in many medical centers.

Society for Academic Emergency Medicine (SAEM)

  • The Society for Academic Emergency Medicine endorses the creation of national research initiatives, including a registry to gather outcomes data for stroke victims, whether or not thrombolytic therapy is administered. Data should include details of the care process, including timeliness and quality of the clinical interventions and adequacy of important support systems. At this time, decisions regarding thrombolytic therapy must be individualized, based on specific clinical and operational circumstances5

National Association of EMS Physicians (NAEMSP)

  • The National Association of EMS Physicians, in its position paper of 2000, stated that EMS medical directors should be aware of available local stroke treatment options, including experimental treatments6

Indication
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).

Safety Information
Activase therapy in patients with AIS is contraindicated in certain situations (eg, suspicion of subarachnoid hemorrhage on pretreatment evaluation, recent (within 3 months) intracranial or intraspinal surgery, history of intracranial hemorrhage, uncontrolled hypertension at time of treatment, active internal bleeding, known bleeding diathesis (eg, current use of oral anticoagulants, administration of heparin within 48 hours of onset of stroke, platelet count <100,000) (see CONTRAINDICATIONS for full list).

The most common complication during Activase therapy is bleeding. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, Activase therapy should be discontinued immediately. Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.

The risks of Activase therapy may be increased and should be weighed against the anticipated benefits in certain conditions. [See WARNINGS in full prescribing information].

  • Patients with severe neurological deficit (eg, NIHSS >22) at presentation. There is an increased risk of intracranial hemorrhage in these patients.
  • Patients with major early infarct signs on a computerized cranial tomography (CT) scan (eg, substantial edema, mass effect, or midline shift).

Treatment of patients with minor neurological deficit or with rapidly improving symptoms is not recommended.

Orolingual angioedema has been observed in postmarketing experience in patients treated with Activase for AIS. Patients should be monitored during and for several hours after infusion for signs of orolingual angioedema.

Please click here for full prescribing information.
References:
1.
Adams HP Jr, del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke. Stroke. 2007;38:1655-1711.
2.
American Academy of Neurology (AAN) Practice advisory: thrombolytic therapy for acute ischemic stroke — summary statement. Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 1996;47:835-839. http://www.aan.com/professionals/practice/pdfs/gl0025.pdf. Accessed March 24, 2009.
3.
American College of Emergency Physicians (ACEP). Use of intravenous tPA for the management of acute stroke in the emergency department. Ann Emerg Med. 2002;40:551. http://www.acep.org/practres.aspx?id=29834. ACEP Policy Statements. Accessed March 24, 2009.
4.
Alberts MJ, Latchaw RE, Selman WR, et al, for the Brain Attack Coalition. Recommendations for comprehensive stroke centers: a consensus statement from the Brain Attack Coalition. Stroke. 2005;36;1597-1616.
5.
Society for Academic Emergency Medicine. SAEM position on optimizing care of the stroke patient. SAEM Newsletter. 2003;15(3):8. http://www.saem.org/newsltr/2003/may-june/strokeptcare.pdf. Accessed May 29, 2009.
6.
Sahni R; for the National Association of EMS Physicians Standards and Clinical Practice Committee. Acute stroke: implications for prehospital care. Prehosp Emerg Care. 2000;4:270-272.