Inclusion criteria |
Clinical diagnosis of ischemic stroke causing measurable neurologic deficit |
Onset of symptoms <4.5 hours before beginning treatment; if the exact time of stroke onset is not known, it is defined as the last time the patient was known to be normal or at neurologic baseline |
Age ≥18 years |
Exclusion criteria |
Patient history |
Ischemic stroke or severe head trauma in the previous three months |
Previous intracranial hemorrhage |
Intra-axial intracranial neoplasm |
Gastrointestinal malignancy |
Gastrointestinal hemorrhage in the previous 21 days |
Intracranial or intraspinal surgery within the prior three months |
Clinical |
Symptoms suggestive of subarachnoid hemorrhage |
Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg) |
Active internal bleeding |
Presentation consistent with infective endocarditis |
Stroke known or suspected to be associated with aortic arch dissection |
Acute bleeding diathesis, including but not limited to conditions defined under 'Hematologic' |
Hematologic |
Platelet count <100,000/mm3* |
Current anticoagulant use with an INR >1.7 or PT >15 seconds or aPTT >40 seconds* |
Therapeutic doses of low molecular weight heparin received within 24 hours (eg, to treat VTE and ACS); this exclusion does not apply to prophylactic doses (eg, to prevent VTE) |
Current use (ie, last dose within 48 hours in a patient with normal renal function) of a direct thrombin inhibitor or direct factor Xa inhibitor with evidence of anticoagulant effect by laboratory tests such as aPTT, INR, ECT, TT, or appropriate factor Xa activity assays |
Head CT |
Evidence of hemorrhage |
Extensive regions of obvious hypodensity consistent with irreversible injury |
Warnings¶ |
Only minor and isolated neurologic signs or rapidly improving symptomsΔ |
Serum glucose <50 mg/dL (<2.8 mmol/L)◊ |
Serious trauma in the previous 14 days§ |
Major surgery in the previous 14 days¥ |
History of gastrointestinal bleeding (remote) or genitourinary bleeding‡ |
Seizure at the onset of stroke with postictal neurologic impairments† |
Pregnancy** |
Arterial puncture at a noncompressible site in the previous seven days¶¶ |
Large (≥10 mm), untreated, unruptured intracranial aneurysm¶¶ |
Untreated intracranial vascular malformation¶¶ |
Additional warnings for treatment from 3 to 4.5 hours from symptom onsetΔΔ |
Age >80 years |
Oral anticoagulant use regardless of INR |
Severe stroke (NIHSS score >25) |
Combination of both previous ischemic stroke and diabetes mellitus |