Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN) "TALISMAN"

Withdrawn

Phase 2/3 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • 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

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Neurological outcome 90 days No
Secondary Symptomatic intracranial hemorrhage 24 hours Yes

Sponsors