Clinical outcomes and safety profile of Tenecteplase in wake-up stroke

Acta Neurol Scand. 2020 Nov;142(5):475-479. doi: 10.1111/ane.13296. Epub 2020 Jun 23.


Background: Tenecteplase has probably pharmacological and clinical advantages in the treatment of acute ischemic stroke. There are lacking data about safety and efficacy of tenecteplase in wake-up stroke (WUPS).

Aims: To investigate safety and efficacy of tenecteplase compared to alteplase in WUPS patients included in NOR-TEST.

Methods: WUPS patients in NOR-TEST were included in the study based on DWI-FLAIR mismatch. Included patients randomly assigned (1:1) to receive intravenous tenecteplase 0.4 mg/kg (to a maximum of 40 mg) or alteplase 0.9 mg/kg (to a maximum of 90 mg). Neurological improvement was defined as 1) favorable functional outcome at 90 days modified Rankin Scale (mRS) of 0 or 1 and 2) neurological improvement measured with the National Institutes of Health Stroke Scale (NIHSS) of 4 points within 24 hours as compared to admission NIHSS or NIHSS 0 at 24 hours.

Results: Of 1100 patients from 13 stroke centers included in NOR-TEST, 45 were WUPS patients. Of these, 5 patients were stroke mimics and excluded. Of the remaining 40 patients (3.6%), 24 were treated with alteplase (60%). There was no difference in the number of patients achieving a good clinical outcome (mRS 0-1) in either treatment group. Patients treated with tenecteplase showed a better early neurological improvement (87.5% vs 54.2%, P = 0.027). No ICH was detected on MRI/CT 24-28 hours after thrombolysis.

Conclusions: In WUPS patients treated in NOR-TEST, there was no difference in clinical outcomes at 90 days and no ICH events or deaths were observed in either alteplase- or tenecteplase-treated patients. Clinical Trial Registration-URL: Unique identifier: NCT01949948.

Keywords: MRI; Tenecteplase; alteplase; wake-up stroke.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Female
  • Fibrinolytic Agents / therapeutic use*
  • Humans
  • Ischemic Stroke / drug therapy*
  • Male
  • Middle Aged
  • Tenecteplase / therapeutic use*
  • Thrombolytic Therapy / methods*
  • Tissue Plasminogen Activator / therapeutic use*
  • Treatment Outcome


  • Fibrinolytic Agents
  • Tissue Plasminogen Activator
  • Tenecteplase

Associated data