Stroke

Reteplase vs. alteplase in patients with acute ischemic stroke

January 8, 2024

Reteplase is a more affordable new-generation thrombolytic with a prolonged half-life. In this phase 2 clinical trial, researchers aimed to determine the safety dose range of reteplase for patients with acute ischemic stroke within 4.5 hours of onset. They found that reteplase was as well-tolerated as alteplase.

• In this multicenter, prospective, randomized controlled, open-label, blinded-end point phase 2 clinical trial, 180 patients with acute ischemic stroke were randomly assigned to receive IV reteplase 12+12 mg (n=61), IV reteplase 18+18 mg (n=67), or IV alteplase 0.9 mg/kg (n=52).
• Symptomatic intracranial hemorrhage occurred in 3 of 60 (5.0%) in the reteplase 12+12 mg group, 1 of 66 (1.5%) in the reteplase 18+18 mg group, and 1 of 50 (2.0%) in the alteplase group (P=0.53). 
• The primary efficacy outcome (proportion of patients with an NIH stroke scale score of no more than one or a decrease of at least four points from baseline at 14 days after thrombolysis) in the modified intention-to-treat population occurred in 45 of 60 (75.0%) in the reteplase 12+12 mg group (odds ratio [OR], 0.85; 95% confidence interval [CI], 0.35-2.06), 48 of 66 (72.7%) in the reteplase 18+18 mg group (OR, 0.75; 95% CI, 0.32-1.78), and 39 of 50 (78.0%) in the alteplase group.

Source:

Li S, et al. (2023, December 28). Stroke. Safety and Efficacy of Reteplase Versus Alteplase for Acute Ischemic Stroke: A Phase 2 Randomized Controlled Trial. https://pubmed.ncbi.nlm.nih.gov/38152962/