Tenecteplase Noninferior to Alteplase in Acute Ischemic Stroke

Study at a glance:

• Journal: New England Journal of Medicine, 2025

• Population: 1,489 Chinese adults with acute ischemic stroke within 4.5 hours of symptom onset

• Method: Multicenter, randomized, open-label, noninferiority trial comparing intravenous tenecteplase (0.25 mg/kg) versus alteplase (0.9 mg/kg)

• Key Finding: Tenecteplase was noninferior to alteplase for functional recovery at 90 days with similar safety

Summary:
This multicenter trial assessed whether tenecteplase, a bioengineered thrombolytic, is noninferior to alteplase in acute ischemic stroke (AIS). A total of 1,489 patients were randomized within 4.5 hours of symptom onset. The primary outcome, excellent functional outcome at 90 days (mRS score 0–1), was achieved in 72.7% of tenecteplase patients and 70.3% of alteplase patients (risk ratio 1.03; 95% CI, 0.97–1.09), meeting the noninferiority margin. Symptomatic intracerebral hemorrhage occurred in 1.2% of patients in each group, and 90-day mortality was similar (4.6% vs 5.8%).

Takeaway:
Tenecteplase is a safe and effective alternative to alteplase for intravenous thrombolysis in patients with acute ischemic stroke within 4.5 hours of onset.

Source (AMA style with link):
Yan S, Zhou Y, Lansberg MG, et al. Tenecteplase versus alteplase for acute ischemic stroke within 4.5 hours. N Engl J Med. 2025;392(13):1288-1296. doi:10.1056/NEJMoa2413344. Available at: https://jamanetwork.com/journals/jama/fullarticle/2823655 . Accessed September 29, 2025.