A similar effect of fibrinogen on efficacy and safety of tenecteplase

Background and Objectives: Hemostasis factors affecting clot patterns, particularly fibrinogen, may influence the effectiveness of intravenous thrombolysis (IVT). We aimed to investigate the impact of differences in fibrinogen plasma levels on the efficacy and safety of tenecteplase Methods: In a multi-center, prospective, open-label, end-point blinded, randomized, controlled trial. Adults with acute ischemic stroke (AIS) were enrolled. Patients received intravenous tenecteplase (0-25 mg/kg) or alteplase (0-9 mg/kg) within 4-5 h. Patients were divided into three groups according to their plasma fibrinogen level: low fibrinogen level (< 2 g/L), normal fibrinogen level (2-4 g/L), and high fibrinogen level (> 4 g/L). The Modified Rankin Score (mRS) from 2 to 6 was used to define the efficacy outcome. The safety outcomes were the occurrence of symptomatic intracranial hemorrhage (sICH) within 36 h and 90 days, parenchymal hematoma 2 (PH Results: The trial enrolled 1409 patients with AIS. Among them, 705 patients received tenecteplase treatment and 704 patients received alteplase treatment. Six percent of all patients had a low plasma fibrinogen level ( < 2 g/L), 81% had a normal fibrinogen level (2-4 g/L), and 13% had a high plasma fibrinogen level ( > 4 g/L). The efficacy of tenecteplase compared to alteplase remained consistent across varying fibrinogen levels (interaction Conclusion: The results of the study suggest that the efficacy and safety of tenecteplase in treated AIS patients within 4.5 h are comparable to those of alteplase, regardless of plasma fibrinogen levels.