Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis "ATTEST2"

Not yet recruiting

Phase 3 Results N/A

Trial Description

The principle research question is: in patients with acute ischaemic stroke eligible for intravenous (IV) thrombolysis, is tenecteplase superior in efficacy to alteplase, based on functional outcome as assessed by modified Rankin Scale distribution at day 90?

Conditions

Interventions

  • Intravenous rtPA Alteplase Drug
    ARM 1: Kind: Experimental
    Label: Alteplase - standard care
    Description: Alteplase 0.9 mg/kg with 10% of the total dose administered as an initial intravenous bolus and remaining 90% of the total dose administered as an intravenous infusion over 1 hour (maximum dose 90mg).
  • Intravenous Tenecteplase Drug
    ARM 1: Kind: Experimental
    Label: Tenecteplase
    Description: Tenecteplase 0.25mg/kg administered as a single rapid IV bolus (maximum dose 25mg).
  • Intravenous recombinant tissue plasminogen activator (rtPA) Alteplase Drug
    ARM 1: Kind: Experimental
    Label: Alteplase - standard care
    Description: Alteplase 0.9 mg/kg with 10% of the total dose administered as an initial intravenous bolus and remaining 90% of the total dose administered as an intravenous infusion over 1 hour (maximum dose 90mg).

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary modified Rankin Scale Day 90 (+/- 7) No
Secondary Full neurological recovery (mRS 0-1 versus 2-6). Day 90 (+/- 7) No
Secondary Independent recovery (mRS score 0-2 versus 3-6). Day 90 (+/- 7) No
Secondary Early major neurological improvement of 8 or more points, or return to NIHSS total score of 0 or 1 at 24 h. 24 hours No
Secondary Health Related Quality of Life (EQ-5D) Day 90 (+/- 7) No
Secondary Barthel Index score Day 90 (+/- 7) No
Secondary Full neurological recovery (modified Rankin Scale 0-1 versus 2-6). Day 90 (+/- 7) No
Secondary Independent recovery (modified Rankin Scale score 0-2 versus 3-6). Day 90 (+/- 7) No
Secondary Early major neurological improvement of 8 or more points, or return to the National Institutes of Health Stroke Scale (NIHSS) total score of 0 or 1 at 24 hour(s). 24 hours No
Secondary Health Related Quality of Life (EuroQol five dimensions questionnaire, EQ-5D) Day 90 (+/- 7) No

Sponsors