Safety Of A Second Dose Of Tenecteplase In Selected Acute Ischemic Stroke Patients Not Responding To The First Dose
Memorial Hermann Health System
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,
Description
Background: Patients who are eligible for "IVT only" (IVT-O) represent the largest cohort of acute ischemic stroke (AIS) patients who are eligible for IVT, approximately three times larger than those who qualify for both IVT and endovascular thrombectomy (EVT). In all studies of IVT, at least 50% of patients remain disabled at 90 days, generating interest in finding treatments that might augment the beneficial effects of IVT, especially in the majority of AIS patients for whom EVT is not an option. The approved standard doses of tissue plasminogen activator (tPA) and TNK, while based on limite…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 * Sy…
Interventions
- DrugTenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
All patients will receive a second dose of tenecteplase.
Location
- Memorial Hermann HospitalHouston, Texas