Appropriate patient selection for Activase® is vital in the treatment of acute ischemic stroke (AIS)

Determine patient eligibility by incorporating the following steps:

Identify potentially eligible patients 5

  • Activase is indicated for the treatment of AIS
  • Prior to initiation of treatment, exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms
  • Initiate treatment as soon as possible, but within 3 hours after symptom onset

Confirm contraindicaitons and consider the warnings and precautions 5


  • Do not administer Activase to treat AIS in the following situations, in which the risk of bleeding is greater than the potential benefit: 
    • Current intracranial hemorrhage (ICH)
    • Subarachnoid hemorrhage
    • Active internal bleeding
    • Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma
    • Presence of intracranial conditions that may increase the risk of bleeding
    • Bleeding diathesisa
    • Current severe uncontrolled hypertension

aThe 2016 AHA/ASA scientific rationale for the inclusion and exclusion criteria for IV alteplase in AIS also advises against treatment with IV alteplase in patients 3

  • With a platelet count <100,000/mm3, international normalized ratio (INR) >1.7, activated partial thromboplastin time (aPTT) >40 seconds, or prothrombin time (PT) >15 seconds
  • Who have a history of warfarin use and an INR >1.7
  • Who have received a dose of low-molecular-weight heparin within the previous 24 hours
  • Who are taking direct thrombin inhibitors or direct Xa inhibitors, unless the laboratory tests are normal or the patient has not received a treatment dose of these agents for >48 hours

Warnings and Precautions:

  • Monitor patients and take the necessary measures in the following situations:


Activase can cause significant, sometimes fatal, internal or external bleeding, especially at arterial and venous puncture sites. Avoid intramuscular injections and trauma to the patient. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Heparin, aspirin, or Activase may cause bleeding complications; therefore carefully monitor for bleeding. If serious bleeding occurs, terminate the Activase infusion.

Orolingual Angioedma

Monitor patients during and for several hours after infusion for orolingual angioedma. If angioedma develops, discontinue the Activase infusion and promptly institute appropriate therapy. 

Cholesterol Embolization

Cholesterol embolization, sometimes fatal, has been reported rarely in patients treated with thrombolytic agents.

Coagulation Tests May be Unreliable during Activase Therapy

Coagulation tests and/or measures of fibrinolytic activity may be unreliable during Activase therapy.