Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke "EXTEND-IA TNK"

Active, not recruiting

Phase 2 Results N/A

Trial Description

Patients presenting to the emergency department with acute ischemic stroke, who are are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for major vessel occlusion to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to intravenous alteplase or tenecteplase before all participants undergo intra-arterial clot retrieval. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.

Conditions

Interventions

  • Tissue plasminogen activator (Activase®)Drug
    Other Names: Alteplase; tPA
    ARM 1: Kind: Experimental
    Label: Intravenous tissue plasminogen activator (tPA)
    Description: Patients will receive intravenous t-PA at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.
  • Tenecteplase (TNKase)Drug
    Other Names: TNK
    ARM 1: Kind: Experimental
    Label: Intravenous tenecteplase (TNK)
    Description: Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds).

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of patients with substantial angiographic reperfusion (assessed as a modified Treatment In Cerebral Ischemia (mTICI) score of 2b/3 (restoration of blood flow to >50% of the affected arterial territory) at initial angiogram. Initial angiogram (day 0) No
Secondary Proportion of patients with complete angiographic reperfusion (mTICI 3) at initial angiogram. Initial angiogram (day 0) No
Secondary Median percentage reperfusion at 24 hrs post stroke, adjusted for site of occlusion (CT or MR perfusion imaging). 24 hours post stroke onset No
Secondary Favourable clinical response at 3 days 3 days post stroke No
Secondary Modified Rankin Scale (mRS) at 3 months 3 months post stroke No
Secondary mRS 0-1 or no change from baseline at 3 months 3 months post stroke No
Secondary mRS 0-2 or no change from baseline at 3 months 3 months post stroke No
Secondary Symptomatic intracranial hemorrhage (SICH) assessed as a large parenchymal hematoma on CT or MR within 36hr of treatment combined with a clinical deterioration of >/= 4 points on the National Institutes of Health Stroke Scale Score (NIHSS) within 36 hours post treatment Yes
Secondary Death due to any cause 3 months post stroke Yes
Primary Proportion of patients with substantial angiographic reperfusion (mTICI) score of 2b/3 (restoration of blood flow to >50% of the affected arterial territory) or absence of retrievable thrombus at initial angiogram. Initial angiogram (day 0)
Secondary Proportion of patients with ≥8 point reduction in NIHSS or reaching 0-1 at 3 days (favourable clinical response) adjusted for baseline NIHSS and age. Initial angiogram (day 0)
Secondary Symptomatic intracranial hemorrhage (SICH) within 36 hours post treatment
Secondary Proportion of patients with angiographic reperfusion adjusted for hyperdense clot length on non-contrast CT and time from thrombolysis to initial angiogram Up to 24 hours post treatment

Sponsors