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

Location:

Jacksonville, Fla.

Trial status:

Open for Enrollment

Why is this study being done?

This pilot trial will be the first step toward direct comparison of delivery of endovascular reperfusion therapy to intravenous 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.

Who is eligible to participate?

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 - INR ≥ 1.7 - Known history of bleeding diathesis

Last updated:

2/5/2014

NCT ID:

NCT01869478

IRB Number:

12-002496