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

Part of paid clinical trials in Houston, Texas.

Sponsor
Memorial Hermann Health System
Study ID
NCT06801054
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) — DRUG
    All patients will receive a second dose of tenecteplase.

Study Details

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 Dates

Start date
Jul 1, 2025
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients receiving double dose TNK
    The investigators will give a second dose of IV TNK to patients receiving the initial TNK dose within 3 hrs of LKN, have a baseline 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 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 MSU or ED, and the second dose in the ED.

Primary Outcome Measure

The number of patients with symptomatic intracerebral hemorrhage or major systemic bleeding [ Time Frame: within 36 hours of enrollment (2nd dose of tenecteplase) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Hermann HospitalHoustonTexas77030
James c Grotta, MD
[email protected]
713 704 3953
Aryn Knight, RN
[email protected]
7137045668
james c Grotta, MD (PRINCIPAL_INVESTIGATOR)
Alexandra l Czap, MD (SUB_INVESTIGATOR)
andrew barreto, MD (SUB_INVESTIGATOR)
Ritvij Bowry, MD (SUB_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Memorial Hermann Hospital· Houston, TX

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