Study for the Use of Alteplase in Patients Who Awaken With Stroke "AWOKE"

Withdrawn

Phase 1 Results N/A

Trial Description

This is a pilot study of thrombolytic therapy in patients with ischemic stroke who present with stroke symptoms upon awakening.

Detailed Description

Patients with ischemic stroke are currently only eligible for the treatment with intravenous thrombolysis if the stroke is diagnosed within 4.5 hours from known onset of symptoms.
Many patients awaken with stroke and are excluded from this therapy, following current guidelines.
Patients who suffer from a stroke just before or after waking up may be candidates for thrombolysis and our study will use advanced neuroimaging to select those patients.

Conditions

Interventions

  • Alteplase (tPA) Drug
    Other Names: Activase®; rt-PA; t-PA; tPA
    Intervention Desc: 0.9mg/KG (maximum 90mg), 10% bolus over one minutes, remainder over one hour.
    ARM 1: Kind: Experimental
    Label: Alteplase
    Description: Alteplase 0.9mg/kg (maximum 90mg), 10% IV bolus over 1 minute and the remainder over one hour infusion in patients with ischemic stroke after awaking.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Symptomatic Intracranial Hemorrhage 0-72 hours Yes
Secondary Modified Rankin Scale 90 days No
Secondary National Institutes of Health Stroke Scale (NIHSS) 24 hours No

Sponsors