Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke "EARLY"


Phase 2 Results

Eligibility Criteria

Inclusion Criteria

- Age ≥ 18 years
- Definite or probable ischemic stroke
- CT angiographic (CTA) evidence of intracranial vascular occlusion (internal carotid, middle cerebral - M1 or M2 divisions, anterior cerebral, posterior cerebral, or basilar artery) within 3.5 hours of symptom onset
- Able to receive assigned treatment within 4.5 hours of symptom onset
- Written informed consent from patient or surrogate, if unable to provide consent

Exclusion Criteria

- CT evidence of early infarction in >1/3 of middle cerebral artery distribution
- Blood pressure > 185/110 mmHg refractory to anti-hypertensive therapy
- History of intracranial hemorrhage
- History of ischemic stroke within past 3 months
- History of major surgical procedure within past 14 days
- Gastrointestinal or genitourinary bleeding within past 14 days
- Glucose <50 or >400mg/dL
- Platelet count <100,000
- International normalized ratio (INR) ≥ 1.7
- Known history of bleeding diathesis