PT  - JOURNAL ARTICLE
AU  - Li, Shuya
AU  - Pan, Yuesong
AU  - Wang, Ziran
AU  - Liang, Zhigang
AU  - Chen, Huisheng
AU  - Wang, Dong
AU  - Sui, Yi
AU  - Zhao, Xingquan
AU  - Wang, Yilong
AU  - Du, WanLiang
AU  - Zheng, Huaguang
AU  - Wang, Yongjun
TI  - 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
AID  - 10.1136/svn-2021-000978
DP  - 2022 Feb 01
TA  - Stroke and Vascular Neurology
PG  - 47--53
VI  - 7
IP  - 1
4099  - http://svn.bmj.com/content/7/1/47.short
4100  - http://svn.bmj.com/content/7/1/47.full
SO  - Stroke Vasc Neurol2022 Feb 01; 7
AB  - 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.Data are available on reasonable request.