To determine the appropriate dose of tenecteplase (TNK-TPA), a form of tissue plasminogen activator, in patients with acute ischemic stroke.
- Tenecteplase (TNKase)Drug
Other Names: Metalyse Intervention Desc: Intravenous thrombolytic agent. Bioengineered plasminogen activator, similar to tissue plasminogen activator.
Pilot, dose-escalation safety study.
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).
|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).|