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

Endovascular Arterial Reperfusion vs. Intravenous ThromboLYsis for Acute Ischemic Stroke (EARLY): A Randomized Pilot Study of Ultra-early (<2 Hours) and Early (2-4.5 Hours) Reperfusion Therapy

This pilot trial will be the first step toward direct comparison of delivery of endovascular reperfusion therapy to intravenous recombinant tissue plasminogen activator (rt-PA) in a time-to-treatment framework shown as most effective by the NINDS rt-PA Stroke Trial. A randomized trial is justified for the following reasons: 1) The high rate of death and disability associated with ischemic stroke despite treatment with intravenous rt-PA mandates critical analysis of alternate therapies with therapeutic potential, 2) endovascular treatment for acute ischemic stroke is expanding in North America without compelling evidence of safety and efficacy from well-designed clinical trials, 3) critical cost-effectiveness analysis cannot be done without acquiring pertinent outcomes data from controlled studies.

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