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

• DOI: 10.1136/svn-2021-000978
• Publication Date: 2021-08-24T17:05:51Z
• Authors: Shuya Li; Yuesong Pan; Ziran Wang; Zhigang Liang; Huisheng Chen; Dong Wang; Yi Sui; Xingquan Zhao; Yilong Wang; WanLiang Du; Huaguang Zheng; Yongjun Wang
• Keywords: Tenecteplase; Clinical endpoint; Stroke; Fibrinolytic agent

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