NCT06801054Not yet recruitingPhase 1
Safety Of A Second Dose Of Tenecteplase In Selected Acute Ischemic Stroke Patients Not Responding To The First Dose
Source: ClinicalTrials.gov · Last updated 5 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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,
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 24 Jan 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Memorial Hermann Health System
- Diseases
- Stroke
- NCT number
- NCT06801054
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 1 Jul 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving more than one antiplatelet agent during the 48 hours prior to enrollment
- Patients taking lecanemab, donanemab, or other amyloid reduction therapy
- Treatment with a thrombolytic within the last 3 months prior to enrollment
- Intracranial or intraspinal surgery or trauma within 2 months
- Current participation in another investigational drug or device study
Other illness
- Pre-stroke mRS \> 2
- Active internal bleeding
- Patients with undiagnosed significant cognitive impairment or known cerebral amyloid angiopathy
- Known bleeding diathesis
- History of acute ischemic stroke in the last 90 days
- History of hemorrhagic stroke
- Other serious, advanced, or terminal illness (investigator's judgment) or life expectancy is less than 6 months
- Known hypersensitivity or allergy to any ingredients of TENECTEPLASE
Lab values
- 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.
- 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
Other
- 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
- Use of one of the direct oral anticoagulants within the last 48 hours (dabigatran, rivaroxaban, apixaban, edoxaban)
- Presumed septic embolus; suspicion of bacterial endocarditis
- Pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Hermann Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.