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In acute ischemic stroke
Activase (Alteplase) makes a positive
clinical difference*

See how Activase (t-PA) may reverse neurologic impairment*

This hypothetical representation of 16 patients treated with Activase (t-PA) vs 16 patients treated with placebo is based on NINDS results at 3 months.1

Net clinical benefit

In this illustration, 1 of the mortalities in the Activase (t-PA) group could be due to SICH.

Patients treated with Activase (t-PA)   Patients treated with placebo
Patients with symptomatic intracranial hemorrhage (SICH)†


  • Outcomes reflect data reported in Figure 2 of Part 2 of the NINDS study, applied to this hypothetical patient population1
  • Assignment to disability levels is based on average percentage per group on all 4 assessment scales (NIHSS, Barthel Index, Modified Rankin Scale, and Glasgow Outcome Scale)

NINDS study design: The National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Study was a randomized, double-blind, placebo-controlled study of patients with acute ischemic stroke treated with intravenous recombinant tissue plasminogen activator (t-PA) or placebo. At 3 months (N=333), a global test statistic was used to assess clinical outcomes. Favorable outcome was defined as NIHSS, <1; Barthel Index, 95 or 100; Modified Rankin Scale, 0 or 1; and Glasgow Outcome Scale, 1.

In NINDS, when eligible patients were treated with Activase (t-PA) compared with placebo1:

  • More stroke victims sustained minimal to no disability (31% vs 20%†)
  • Fewer had moderate-to-severe disability (52% vs 59%†)
  • There was no statistically significant difference in overall mortality (17% vs 21%; P=0.30)
  • Approximately half of patients experiencing SICH had nonfatal outcomes at 36 hours
    • – 55% (11 of 20) of patients treated with Activase (t-PA) and 50% (1 of 2) of patients given a placebo
    • – The rate of SICH among patients treated with Activase (t-PA) was 6.4% vs 0.6% with placebo (P<0.001) at 36 hours
  • *
  • Defined by the National Institutes of Health Stroke Scale (NIHSS) score compared to baseline.
  • †
  • Based on NIHSS score comparison; trend consistent across remaining 3 outcome scales.
The average stroke patient loses 32,000 brain cells everyone second.(30) Reperfusion offers the potential to reduce the extent of ischemic injury(3,4)

Why choose to reperfuse?

  • Activase (t-PA) may reverse neurologic impairment* through a targeted mechanism of action (MOA) View Activase (t-PA) MOA video
  • More stroke patients recover with minimal or no disability at 3 months and 1 year4,5
  • Numerous studies support the safety of Activase (t-PA)6-28
  • Over a decade of real-world experience in >150,000 patients29

* Defined by the National Institutes of Health Stroke Scale (NIHSS) score compared to baseline.

Activase (t-PA) is part of stroke management guidelines or statements of:

Genentech is neither affiliated with nor endorses any of these organizations.

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.
The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;33:1581-1587.
2.
American Heart Association/American Stroke Association. Stroke Journal Report. December 9, 2005. http://www.americanheart.org/presenter.jhtml?identifier=3036010. Accessed June 6, 2007.
3.
González RG. Imaging-guided acute ischemic stroke therapy: from "time is brain" to "physiology is brain". Am J Neuroradiol. 2006;27:728-735.
4.
Donnan GA, Davis SM. Neuroimaging, the ischaemic penumbra, and selection of patients for acute stroke therapy. Lancet Neurol. 2002;1:417-425.
5.
Kwiatkowski TG, Libman RB, Frankel M, et al. Effects of tissue plasminogen activator for acute ischemic stroke at one year. N Engl J Med. 1999;340:1781-1787.
6.
Akins PT, Delemos C, Wentworth D, Byer J, Schorer SJ, Atkinson RP. Can emergency department physicians safely and effectively initiate thrombolysis for acute ischemic stroke? Neurology. 2000;55:1801-1805.
7.
Albers GW, Bates VE, Clark WM, Bell R, Verro P, Hamilton SA. Intravenous tissue-type plasminogen activator for treatment of acute stroke: the Standard Treatment with Alteplase to Reverse Stroke (STARS) study. JAMA. 2000;283:1145-1150.
8.
Albright KC, Schott TC, Jafari N, et al. Tissue plasminogen activator use: evaluation and initial management of ischemic stroke from an Iowa hospital perspective. J Stroke Cerebrovasc Dis. 2005;14:127-135.
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Asimos AW, Norton J, Price MF, Cheek WM. Therapeutic yield and outcomes of a community teaching hospital code stroke protocol. Acad Emerg Med. 2004;11:361-370.
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Bateman BT, Schumacher HC, Boden-Albala B, et al. Factors associated with in-hospital mortality after administration of thrombolysis in acute ischemic stroke patients: an analysis of the nationwide inpatient sample 1999 to 2002. Stroke. 2006;37:440-446.
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Bravata DM, Kim N, Concato J, Krumholz HM, Brass LM. Thrombolysis for acute stroke in routine clinical practice. Arch Intern Med. 2002;162:1994-2001.
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Buchan AM, Barber PA, Newcommon N, et al. Effectiveness of t-PA in acute ischemic stroke: outcome relates to appropriateness. Neurology. 2000;54:679-684.
13.
Chiu D, Krieger D, Villar-Cordova C, et al. Intravenous tissue plasminogen activator for acute ischemic stroke: feasibility, safety, and efficacy in the first year of clinical practice. Stroke. 1998;29:18-22.
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Dick AP, Straka J. IV tPA for acute ischemic stroke: results of the first 101 patients in a community practice. Neurologist. 2005;11:305-308.
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Grotta JC, Burgin WS, El-Mitwalli A, et al. Intravenous tissue-type plasminogen activator therapy for ischemic stroke. Houston experience 1996 to 2000. Arch Neurol. 2001;58:2009-2013.
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Hill MD, Buchan AM; for the Canadian Alteplase for Stroke Effectiveness Study (CASES) Investigators. Thrombolysis for acute ischemic stroke: results of the Canadian Alteplase for Stroke Effectiveness Study. CMAJ. 2005;172:1307-1312.
17.
Kahn JH, Viereck J, Kase C, et al. The use of intravenous recombinant tissue plasminogen activator in acute ischemic stroke. J Emerg Med. 2005;29:273-277.
18.
Katzan IL, Furlan AJ, Lloyd LE, et al. Use of tissue-type plasminogen activator for acute ischemic stroke: the Cleveland area experience. JAMA. 2000;283:1151-1158.
19.
Katzan IL, Hammer MD, Furlan AJ, Hixson ED, Nadzam DM; on behalf of the Cleveland Clinic Health System Stroke Quality Improvement Team. Quality improvement and tissue-type plasminogen activator for acute ischemic stroke: a Cleveland update. Stroke. 2003;34:799-800.
20.
Lopez-Yunez AM, Bruno A, Williams LS, Yilmaz E, Zurrú C, Biller J. Protocol violations in community-based rtPA stroke treatment are associated with symptomatic intracerebral hemorrhage. Stroke. 2001;32:12-16.
21.
Merino JG, Silver B, Wong E, et al. Extending tissue plasminogen activator use to community and rural stroke patients. Stroke. 2002;33:141-146.
22.
Paul Coverdell Prototype Registries Writing Group. Acute stroke care in the US: results from 4 pilot prototypes of the Paul Coverdell National Acute Stroke Registry. Stroke. 2005;36:1232-1240.
23.
Qureshi AI, Kirmani JF, Sayed MA, et al. Time to hospital arrival, use of thrombolytics, and in-hospital outcomes in ischemic stroke. Neurology. 2005;64:2115-2120.
24.
Reed SD, Cramer SC, Blough DK, Meyer K, Jarvik JG, Wang DZ. Treatment with tissue plasminogen activator and inpatient mortality rates for patients with ischemic stroke treated in community hospitals. Stroke. 2001;32:1832-1840.
25.
Rymer MM, Thrutchley DE; for the Stroke Team at the Mid America Brain and Stroke Institute. Organizing regional networks to increase acute stroke intervention. Neurol Res. 2005;27(suppl 1):S9-S16.
26.
Smith RW, Scott PA, Grant RJ, Chudnofsky CR, Frederiksen SM. Emergency physician treatment of acute stroke with recombinant tissue plasminogen activator: a retrospective analysis. Acad Emerg Med. 1999;6:618-625.
27.
Tanne D, Bates VE, Verro P, et al. Initial clinical experience with IV tissue plasminogen activator for acute ischemic stroke: a multicenter survey. Neurology. 1999;53:424-427.
28.
Wang DZ, Rose JA, Honings DS, Garwacki DJ, Milbrandt JC; for the OSF Stroke Team. Treating acute stroke patients with intravenous tPA: the OSF Stroke Network experience. Stroke. 2000;31:77-81.
29.
Data on file. Genentech, Inc.
30.
Saver JL. Time is brain — quantified. Stroke. 2006;37:263-266.