TNK in Acute Ischemic Stroke [SPOTRIAS]

Completed

Phase N/A Results

Trial Description

To determine the appropriate dose of tenecteplase (TNK-TPA), a form of tissue plasminogen activator, in patients with acute ischemic stroke.

Interventions

  • Tenecteplase (TNKase)Drug
    Other Names: Metalyse
    Intervention Desc: Intravenous thrombolytic agent. Bioengineered plasminogen activator, similar to tissue plasminogen activator.

Trial Design

Pilot, dose-escalation safety study.

Patient Involvement

Three groups of 25 patients each received one of three doses (0.1, 0.2, 0.4 mg/kg) of tenecteplase within 3 hours of stroke onset. Follow-up CT was performed 48 hours after treatment. Outcome was assessed at 7 days, 10 days, and 3 months (Barthel, Glasgow, Rankin).

Outcomes

Type Measure Time Frame Safety Issue
Primary Symptomatic intracranial hemorrhage within 36 hours.
Secondary Neurological improvement at 24 hours (NIHSS), and clinical outcome at 3 months (Rankin).

Sponsors

National Institute for Neurological Disorders and Stroke, NIH