Safety of Intravenous Thrombolysis for Wake-up Stroke "Wake-Up Stroke"

Completed

Phase 2 Results

Trial Description

The purpose is to demonstrate the safety of intravenous tissue plasminogen activator (IV t-PA) in ischemic stroke patients who present to the emergency department (ED) after awakening with the symptoms of suspected ischemic stroke.

Detailed Description

This is an open label, multi-center, safety study of acute treatment with IV alteplase in ischemic stroke patients who wake-up with their symptoms. The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Clinical improvement defined as a decrease in the National Institutes of Health Stroke Scale (NIHSS) score at 24 hours, 3 days and 90 days and modified Rankin Scale (mRS) score at 3 and 90 days. For patients that have computed tomographic angiogram (CTA) and computed tomographic perfusion (CTP), the incidence of large vessel occlusion will be quantified.

Conditions

Interventions

  • Alteplase (iv t-PA) Drug
    Other Names: Activase®; Alteplase; tissue plasminogen activator; t-PA
    Intervention Desc: 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour.
    ARM 1: Kind: Experimental
    Label: off label rt-PA used
    Description: off label rt-PA used on all subject enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Frequency of symptomatic hemorrhagic transformation Safety of iv t-PA in wake up stroke patients 24 hr Yes
Secondary Clinical improvement up to 90 days No
Primary Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients 24 hours Yes
Secondary 90-day Modified Rankin Scale (mRS) Score 0 or 1 90 days No
Secondary Mortality 90 days Yes

Sponsors