Tenecteplase Versus Alteplase in Acute Ischaemic Cerebrovascular Events (Trace-2): A Phase 3, Multicenter, Open-Label, Randomized Controlled, Non-Inferiority Trial
Published on: April 24, 2023
For patients with acute ischemic stroke within 4.5 hours of symptom onset, tenecteplase is non-inferior to alteplase, according to new research. The TRACE-2 study included Chinese adults with an acute ischemic stroke who were eligible for standard I.V. thrombolysis treatment, but ineligible for endovascular thrombectomy. In all, 1,430 patients were randomized to receive either I.V. tenecteplase (N=716, 0.25 mg/kg, maximum dose of 25 mg) or I.V. alteplase (N=714, 0.9 mg/kg, maximum dose of 90 mg). Thirteen patients (6 in the tenecteplase group and 7 in the alteplase group) did not receive the study product, while 16 patients (5 and 11, respectively) were lost to follow-up. At 90 days, the modified intention-to-treat analysis found that 62% (439/705) of patients in the tenecteplase group reached the primary outcome — a modified Rankin Scale (mRS) score of 0-1 — compared with 58% (405/696) of patients in the alteplase group. The difference met the criteria for non-inferiority with a margin of 0.937, but not superiority. Overall, 2% of each group — 15/711 in the tenecteplase group and 13/706 in the alteplase group — had symptomatic intracranial hemorrhage. Mortality in the two groups was 7% (46 patients) and 5% (35 patients), respectively. "The trial results support the implementation of intravenous tenecteplase 0.25 mg/kg as an alternative thrombolytic agent to the standard-of-care alteplase in patients with disabling ischemic stroke within 4.5 hours of stroke onset," the researchers conclude. Future research, they suggest, could investigate the use of I.V. tenecteplase for an extended time frame of up to 24 hours and whether there is a time-dependent treatment effect of I.V. tenecteplase vs. alteplase.