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

Terminated

Phase 2 Results

Trial Description

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.

Trial Stopped: Poor recruitment

Conditions

Interventions

  • Intravenous Thrombolysis Other
    ARM 1: Kind: Experimental
    Label: Intravenous Thrombolysis
    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.
  • Endovascular Arterial Reperfusion Device
    Other Names: Penumbra, Solitaire
    ARM 1: Kind: Experimental
    Label: Endovascular Arterial Reperfusion
    Description: Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Recanalization rate of primary intracranial occlusion 24 hours No
Secondary modified Rankin Scale 90 days No
Secondary Mean Score on Modified Rankin Scale at 90 Days 90 days No

Sponsors