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NCT06801054

PHASE1

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

Sponsor: Memorial Hermann Health System

View on ClinicalTrials.gov

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,

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-07-01

Completion Date

2026-09-30

Last Updated

2025-06-05

Healthy Volunteers

Conditions

Acute Ischemic Stroke

Interventions

DRUG

Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)

All patients will receive a second dose of tenecteplase.

Inclusion Criteria: * Signs and symptoms suggestive of acute ischemic stroke * Age \> 18 and \< 80 years * Time from LKN \< 3 hrs (first dose) and \<4.5 hours (second dose) * NIHSS \> 6 and (for both first and second dose) * CT at baseline and prior to second dose shows no evidence of intracranial hemorrhage and has an ASPECTS score \> 6 * Patient/legally authorized representative has signed the Informed Consent Form Exclusion Criteria: * Patients with LVO or MeVO for whom EVT is intended at any time before the second dose of TENECTEPLASE * At the time of the second dose, NIHSS is \< 6 * Systolic blood pressure \> 180 at the time of either dose of TENECTEPLASE * Pre-stroke mRS \> 2 * Patients receiving more than one antiplatelet agent during the 48 hours prior to enrollment * Active internal bleeding * Patients with undiagnosed significant cognitive impairment or known cerebral amyloid angiopathy * Patients taking lecanemab, donanemab, or other amyloid reduction therapy * Known bleeding diathesis * Recent use of heparin with PTT \> control * Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; known administration of warfarin within 24 hours or suspected use and INR \> 1.5. * Use of one of the direct oral anticoagulants within the last 48 hours (dabigatran, rivaroxaban, apixaban, edoxaban) * Treatment with a thrombolytic within the last 3 months prior to enrollment * Baseline platelet count \< 100,000/μL (results must be available prior to treatment) * Baseline blood glucose \> 400 mg/dL (22.20 mmol/L) * Baseline blood glucose \< 50 mg/dL needs to be normalized prior to enrollment * Intracranial or intraspinal surgery or trauma within 2 months * History of acute ischemic stroke in the last 90 days * History of hemorrhagic stroke * Presumed septic embolus; suspicion of bacterial endocarditis * Other serious, advanced, or terminal illness (investigator's judgment) or life expectancy is less than 6 months * Pregnant * Current participation in another investigational drug or device study * Known hypersensitivity or allergy to any ingredients of TENECTEPLASE

Locations (1)

Memorial Hermann Hospital

Houston, Texas, United States