Lesson 1 of 1
Literature Review 20. TRACE-2
- IV alteplase has been recommended as a standard therapy for eligible patients with acute ischemic stroke. Tenecteplase has a simpler dosing and administration strategy, which makes it an attractive alternative agent to alteplase. Previous data suggests tenecteplase is non-inferior to alteplase with a similar safety profile.
- To determine if tenecteplase is non-inferior to alteplase in Chinese patients with acute ischemic stroke who are eligible for IV thrombolytic therapy but are ineligible for thrombectomy.
- Phase 3, multicenter, prospective, open-label, blinded-endpoint, randomized controlled, non-inferiority trial across 53 centers in China.
Study Intervention & Comparison
- IV tenecteplase (0.25mg/kg) vs IV alteplase (0.9mg/kg)
- Primary Efficacy Outcome
- Proportion of patients with an mRS score of 0-1 at 90 days (62% v 58%, RR 1.07, CI 0.98-1.16)
- Primary Safety Outcome
- Rate of symptomatic hemorrhage at 36hr (2% v 2%, p=0.72)
- Key Secondary Outcomes
- Proportion of patients with favorable functional outcome at 3 months (73% v 72%, p=0.74)
- Proportion of patients with significant neurologic improvement at 7 days or discharge (68% v 66%, p=0.73)
- Any intracranial hemorrhage within 90 days (6% v 7%, p=0.5)
- Parenchymal hematoma 2 within 36hr (1% v <1%, p=0.053)
- Tenecteplase was non-inferior to alteplase in patients with ischemic stroke who were eligible for IV thrombolytic administration but ineligible for endovascular thrombectomy. There were no significant safety differences between the two agents.
- Huang X, Cheripelli BK, Lloyd SM, et al. Alteplase versus tenecteplase for thrombolysis after ischaemic stroke (ATTEST): a phase 2, randomised, open-label, blinded endpoint study. Lancet Neurol. 2015;14(4):368-376.
- Campbell BCV, Mitchell PJ, Churilov L, et al. Effect of intravenous tenecteplase dose on cerebral reperfusion before thrombectomy in patients with large vessel occlusion ischemic stroke: the extend-ia tnk part 2 randomized clinical trial. JAMA. 2020;323(13):1257-1265.
- Logallo N, Novotny V, Assmus J, et al. Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial. Lancet Neurol. 2017;16(10):781-788.
- Menon BK, Buck BH, Singh N, et al. Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, non-inferiority trial. Lancet. 2022;400(10347):161-169.