Safety and efficacy of tenecteplase versus alteplase in patients with acute ischaemic stroke (TRACE): a multicentre, randomised, open label, blinded-endpoint (PROBE) controlled phase II study. Issue 1 (24th August 2021)

• Record Type: Journal Article
• Authors: Li, Shuya; Pan, Yuesong; Wang, Ziran; Liang, Zhigang; Chen, Huisheng; Wang, Dong; Sui, Yi; Zhao, Xingquan; Wang, Yilong; Du, WanLiang; Zheng, Huaguang; Wang, Yongjun
• Is Part Of: Stroke and vascular neurology. Volume 7:Issue 1(2022)
• Page Start: 47
• Page End: 53
• Publication Date: 2021-08-24
• Subjects: stroke -- thrombolysis; Cerebrovascular disease -- Periodicals; Cardiovascular system -- Diseases -- Periodicals; 616.81005
• DOI: 10.1136/svn-2021-000978
• Languages: English
• ISSNs: 2059-8688

Abstract

Abstract : Background: Tenecteplase (TNK) possesses several pharmacological characteristics superior to conventional alteplase (rt-PA), with well-established safety and efficacy profile in Caucasians. There exists controversy over the optimal dose of intravenous rt-PA for East Asians with acute ischaemic stroke (AIS). Current study aimed to determine the safety dose range of recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) for patients with AIS in China. Methods: This multicentre, prospective, randomised, open-label, blinded end-point, phase II study compared three tiers of 0.1, 0.25, 0.32 mg/kg rhTNK-tPA (to a maximum of 40 mg) with standard 0.9 mg/kg rt-PA (to a maximum of 90 mg) in patients who were eligible for intravenous thrombolysis. The safety outcome were symptomatic intracranial haemorrhage (sICH) within 36 hours. Results: Between May 2018 and February 2020, 240 patients were randomly assigned to four group, 4 of whom did not receive study treatment. The intention-to-treat analysis included 236 patients. There was no difference in the improvement on National Institutes of Health Stroke Scale at day 14 in the 3 tiers and control group (63.3%, 77.2%, 66.7% vs 62.7%). The number of sICH was 3 of 60 (5.0%) in the 0.1 mg/kg group, none in the 0.25 mg/kg group, 2 of 60 (3.3%) in the 0.32 mg/kg group and 1 (1.7%) of 59 in the rt-PA group. There were no significant between-group differences in severe adverse events. Conclusions: Similar to the Caucasians, rhTNK-tPA was well tolerated in Chinese patients with AIS at all doses administered within 3 hours of symptom onset. The dose-efficacy profile of rhTNK-tPA needs to be established with future investigations. Trial registration number: NCT04676659 .