Because Every  Minute Matters

Footnotes

• *
  Tenecteplase was administrated within 4.5 hours after onset of stroke symptoms, as a one-time decile-weight-tie bolus dose, based on 0.25 mg/kg for the maximum weight at each tier: < 60 kg, 15 mg tenecteplase; ≥ 60 to < 70 kg, 17.5 mg; ≥ 70 to < 80 kg, 20 mg; ≥ 80 to < 90 kg, 22.5 mg; and ≥ 90 kg, 25 mg.³
• †
  The AcT phase III trial was a multicentre, open-label, parallel-group, registry-linked, randomised trial, in which 1600 patients, presenting within 4.5 hrs of symptom onset, and eligible for thrombolysis, were enrolled from 22 stroke centres across Canada and randomly assigned to tenecteplase (0.25 mg/kg, to a maximum of 25 mg; n=816) or alteplase (0.9 mg/kg to a maximum of 90 mg; n=784). The primary outcome occurred in 36.9% patients receiving tenecteplase and 34.8% patients receiving alteplase (unadjusted RD 2.1% [95% CI -2.6 to 6.9]).³
• §
  In the AcT phase III clinical trial, the rates of AEs (Adverse Event) were similar for tenecteplase compared to alteplase. The main AEs were: death within 90 days (15.3% for tenecteplase vs. 15.4% for alteplase; RD (Risk Difference) -0.1 [95% CI (Confidence Interval) -3.7, 3.5]), symptomatic intracerebral haemorrhage (3.4% vs. 3.2%; RD 0.2 [95% CI -1.5, 2.0]), extracranial bleeding (0.8% vs. 0.8%; RD 0.0 [(95% CI -0.9, 0.8]), and orolingual angio-oedema (1.1% vs. 1.2%; RD -0.1 [95% CI -1.1, 1.0]).³
• IV = Intravenous.

References

1. Metalyse® European Summary of Product Characteristics. (12/2023)

2. Donkor ES. Stroke Res Treat. 2018; 2018:3238165.

3. Menon BK, et al. Lancet 2022; 400:161-169.

4. Bivard A, et al. Lancet Neurol. 2022; 21:520-27.

5. Warach SJ, et al. Stroke 2022; 53:3583-3593.

6. Mahawish K, et al. Stroke 2021; 52:e590-e593.

7. Warach SJ and Saver JL. JAMA Neurol. 2020; 77(10):1203-1204.