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

Terminated

Phase 2 Results

Update History

6 Oct '16
Trial name was updated.
New
Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke
The Summary of Purpose was updated.
New
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.
Old
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.
The eligibility criteria were updated.
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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
Old
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
25 Sep '15
A location was updated in Jacksonville.
New
The overall status was removed for Mayo Clinic in Florida.