Safety Of A Second Dose Of Tenecteplase In Selected Acute Ischemic Stroke Patients Not Responding To The First Dose

• Status: NOT_YET_RECRUITING
• Trial end date: 2026-09-30

Summary

In this pilot safety study, the investigators will give a second dose of Intravenous Tenecteplase (IV TNK) to patients receiving the initial TNK dose within 3 hrs of last known normal (LKN), have a baseline National Institutes of Health Stroke Scale (NIHSS) \> 6, and who do not clinically improve within 45 minutes of the first dose, or who improve but then deteriorate, and can still be treated within 4.5 hours from LKN. Patients will require a second computed tomography (CT) scan to rule out any bleeding, and meet the usual inclusion and exclusion criteria for TNK treatment, before the second dose which must be given within 4.5 hrs of LKN. Both TNK doses will be 0.25 mg/kg. The initial TNK dose may be given on the Mobile Stroke Unit (MSU) or Emergency Department (ED), and the second dose in the ED. Informed consent will be obtained before the second dose is given.

The primary outcome will be symptomatic intracranial hemorrhage (sICH) (SITS-MOST criteria) or serious systemic bleeding within 36 hours. Secondary outcomes will be any intracranial hemorrhage, any bleeding, discharge NIHSS and modified Rankin Score (mRS), and mRS at 90 days (sliding dichotomy).

20 patients will be enrolled. Enrollment will be stopped if more than 3 sICH occur (\> 80% confidence that sICH rate is \> 5%. If successful, this study will be followed by a larger phase 2b controlled safety confirmation and pilot efficacy study,

• Phase: PHASE1

Details

• Lead Sponsor: Memorial Hermann Health System
• Collaborators: Genentech, Inc.; Grotta Stroke Research Foundation; Memorial Hermann Hospital Mobile Stroke Unit; The University of Texas Health Science Center, Houston
• Treatments: Tenecteplase