Wake up Symptomatic Stroke - Benefit of Intravenous Clot Busters or Endovascular Intervention "WASSABI"

Recruiting

Phase 2 Results N/A

Trial Description

The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion studies as an indicator to treat stroke patients with unknown time of onset.

Conditions

Interventions

  • Alteplase Drug
    Intervention Desc: Full dose Intravenous thrombolysis 0.9 mg/kg Maximum dose is 90 mg 10% of the dose will be given over one minute 90% of the dose will be infused over 1 hour Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications Neuro checks every 5 minutes during the infusion Neuro checks every hour after the infusion for 24 hours
    ARM 1: Kind: Experimental
    Label: Intravenous Thrombolysis
    Description: Full dose Intravenous thrombolysis 0.9 mg/kg Maximum dose is 90 mg 10% of the dose will be given over one minute 90% of the dose will be infused over 1 hour Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications Neuro checks every 5 minutes during the infusion Neuro checks every hour after the infusion for 24 hours
  • Anti-platelets and statin Drug
    ARM 1: Kind: Experimental
    Label: Medical Therapy
    Description: Current standard of care per the latest stroke guidelines Permissive Hypertension up to 220 Antipletelets therapy: ASA 81 mg PO daily or Plavix 75 mg PO daily or Aggrenox 225mg PO twice daily Anti-inflammatory therapy: Lipitor 80 mg PO daily or Crestor 20 mg PO daily
  • Intra arterial intervention Procedure
    Intervention Desc: Intra arterial Activase (Maximum dose of 22 mg) MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes) PENUMBRA device (no standard time frame for how long the procedure takes)
    ARM 1: Kind: Experimental
    Label: Intra-Arterial Therapy
    Description: -Choice of therapy per experienced Endovascular surgeon and includes: Intra arterial Activase (Maximum dose of 22 mg) MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes) PENUMBRA device (no standard time frame for how long the procedure takes)

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale (mRS) 90 days No
Secondary National Institute of Health Stroke Scale (NIHSS) 24 hour No
Secondary Thrombolysis In Myocardial Infarction (TIMI) Flow Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure No
Secondary Thomboylsis in Cerebral Ischemia (TICI) flow Pre - will be no more than 1 hour prior to procedure and post will be no more then 1 hour after completion of procedure No
Secondary symptomatic intracranial Hemorrhage (ICH) 72 hours Yes

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