This is a double-blind parallel arm randomized trial aimed to assess efficacy and safety of intravenous Tenecteplase compared to intravenous Alteplase in eligible patients who present with symptoms of acute ischemic stroke within 3 to 4.5 hours from onset.
Patients presenting with symptoms of acute ischemic stroke (AIS) who present within 3 to 4.5 hours of symptom onset and who meet the inclusion criteria for intravenous (IV) thrombolysis will receive, in a randomized, double-blind fashion, either IV Alteplase at 0.9 mg/kg per standard protocol or IV Tenecteplase at 0.25 mg/kg with saline infusion over one hour. Patients must also have no exclusion criteria for IV thrombolysis within the 3 to 4.5 hour window. The only required imaging is non-contrasted CT of the head. Patients will be monitored according to standard post-thrombolytic care. A CT of the head will be performed at 24 hours based on standard protocol or if there is any neurological change. Neurological function at 24 hours using NIHSS and at 3 months based on modified mRS and the NIHSS.
- Tenecteplase (TNKase)Drug
Other Names: Metalyse Intervention Desc: Tenecteplase 0.25 mg/kg IV - Maximum 25 mg ARM 1: Kind: Experimental Label: Tenecteplase Description: Tenecteplase 0.25 mg/kg IV - Maximum dose: 25 mg
- Alteplase Drug
Intervention Desc: Alteplase 0.9 mg/kg IV - Maximum: 90 mg ARM 1: Kind: Experimental Label: Alteplase Description: Alteplase 0.9 mg/kg IV - Maximum dose: 90 mg
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Neurological outcome||90 days||No|
|Secondary||Symptomatic intracranial hemorrhage||24 hours||Yes|
- Reza Behrouz, DO Lead