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Safety of a Second Dose of Tenecteplase for Acute Ischemic Stroke

This study is looking at the safety of giving a second dose of Tenecteplase (TNK) to patients who have had an acute ischemic stroke (a stroke caused by a blood clot). You might be able to join if you are between 18 and 80 years old, experienced stroke symptoms less than 3 hours ago, and did not improve or got worse after your first dose of Tenecteplase. Before the second dose, you would need another CT scan to make sure there's no bleeding in your brain. The main goal of this study is to see how many patients experience serious bleeding, either in the brain or elsewhere in the body, within 36 hours after receiving the second dose. The study plans to enroll 20 patients, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a pilot safety study, and it plans to enroll 20 participants.
What's involved
You would receive a second dose of Tenecteplase. You would also need a CT scan before the second dose to check for bleeding.
Compensation
Not stated in the trial record.
Follow-up
The primary safety outcome is measured within 36 hours of receiving the second dose of Tenecteplase.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06801054

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

Not Yet Recruiting
PHASE1Ages 18–80InterventionalTreatment
Memorial Hermann Health System
~20 participants
Updated 2025-06-05 on ClinicalTrials.gov
What's tested:Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of patients with symptomatic intracerebral hemorrhage or major systemic bleeding
Measured over within 36 hours of enrollment (2nd dose of tenecteplase)

Conditions

Acute Ischemic Stroke

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NCT06801054

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Hermann Hospital

    Houston, Texasstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

James c Grotta, MD
[email protected]
713 704 3953
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • The number of patients with symptomatic intracerebral hemorrhage or major systemic bleedingwithin 36 hours of enrollment (2nd dose of tenecteplase)

    A type 2 parenchymal hemorrhage or a parenchymal hemorrhage remote from the area of infarction with neurological deterioration (≥4-point worsening in National Institutes of Health Stroke Scale) and major hemorrhage (requiring \>2 units packed red blood cells)