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

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Tissue Plasminogen Activator

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