Safety of Intravenous Thrombolytics in Stroke on Awakening "SAIL-ON"

Recruiting

Phase 2 Results N/A

Trial Description

The primary objective of this study is to evaluate the safety of intravenous tPA in patients waking up with symptoms of acute stroke and presenting to the ED within 4.5 hours from awakening, and meeting standard criteria for treatment with IV tPA for acute stroke.
The hypothesis is that patients that wake up with stroke symptoms may have developed the stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the ED within that time, therefore IV tPA should be safe and effective in this population.

Conditions

Interventions

  • Rt-PA Drug
    Other Names: Actilyse
    Intervention Desc: IV rt-PA 0.9 mg/kg minimum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target foor to needle time of 60 minutes or less from ED arrival.
    ARM 1: Kind: Experimental
    Label: IV rt-PA
    Description: Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary symptomatic intracerebral hemorrhage within 36 hours of treatment Yes
Secondary Functional outcome. 90 days No

Sponsors