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

Mayo Clinic

Status and phase: Terminated; Phase 2

Conditions: Ischemic Stroke; Stroke

Treatments: Device: Endovascular Arterial Reperfusion; Drug: Intravenous Thrombolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT01869478

12-002496

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Intravenous Thrombolysis

Active Comparator group

Description:

0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.

Treatment:

Drug: Intravenous Thrombolysis

Endovascular Arterial Reperfusion

Active Comparator group

Description:

Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.

Treatment:

Device: Endovascular Arterial Reperfusion