In acute ischemic stroke—across a broad range of settings
Safety consistently demonstrated1-3

Symptomatic ICH in clinical practice*

Adapted from Graham GD. Stroke. 2003;34:2847-2850; and Katzan IL, et al. Stroke. 2003;34:799-800.

Cleveland (2000) study evaluated 29 area hospitals. Cleveland Clinic Health System (CHS) studies later evaluated a subset of 9 hospitals. The Cleveland CHS results were not factored into the overall 5.2% rate of ICH in "ALL STUDIES."

  • *
  • Symptomatic intracranial hemorrhage (SICH) percentages are for bleeding within the first 36 hours or the closest reported time point.
  • †
  • Indicates retrospective study; all others were prospective.

Results from meta-analysis of symptomatic ICH in 15 published, open-label studies (N>2600) of Activase (t-PA)1,2:

The risks of Activase (t-PA) therapy to treat acute ischemic stroke may be increased in the following conditions:

  • Patients with severe neurological deficit (eg, NIH Stroke Scale score >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)

NINDS pivotal trial:

  • 6.4% incidence of symptomatic ICH within first 36 hours3
    • – Significantly higher than among placebo patients (0.6%, P<0.001)
The Cleveland Clinical Health System experience

Adapted from Katzan IL, et al. Stroke. 2003;34:799-800.

  • ‡
  • One tertiary care center and 8 community hospitals.
  • §
  • Protocol deviations included: (1) treatment beyond 3 hours (n=7), anticoagulation within 24 hours (n=1), and deviations from blood pressure guidelines (n=3).
  • ||
  • t-PA administration among all admitted ischemic stroke patients.

After implementing a 2-year quality improvement program at 9 Cleveland network hospitals1:

  • Protocol violations were reduced by nearly half1
  • 6.4% incidence of symptomatic ICH, the same as in NINDS1

Indication: Activase 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 in the full prescribing information).

Safety Information: All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in appropriate patients. Not all patients with acute ischemic stroke will be eligible for Activase therapy, including patients with evidence of recent or active bleeding; recent (within 3 months) intracranial or intraspinal surgery, serious head trauma, or previous stroke; uncontrolled high blood pressure; or impaired blood clotting.


Please see full prescribing information.


References:
1.
Katzan IL, Hammer MD, Furlan AJ, et al. Quality improvement and tissue-type plasminogen activator for acute ischemic stroke: a Cleveland update. Stroke. 2003;34:799-800.
2.
Graham GD. Tissue plasminogen activator for acute ischemic stroke in clinical practice: a meta-analysis of safety data. Stroke. 2003;34:2847-2850.
3.
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;333:1581-1587.
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