PT  - JOURNAL ARTICLE
AU  - Li, Shuya
AU  - Campbell, Bruce C V
AU  - Schwamm, Lee H
AU  - Fisher, Marc
AU  - Parsons, Mark
AU  - Li, Hao
AU  - Pan, Yuesong
AU  - Wang, Yongjun
ED - 
TI  - Tenecteplase Reperfusion therapy in Acute ischaemic Cerebrovascular Events-II (TRACE II): rationale and design
AID  - 10.1136/svn-2021-001074
DP  - 2022 Feb 01
TA  - Stroke and Vascular Neurology
PG  - 71--76
VI  - 7
IP  - 1
4099  - http://svn.bmj.com/content/7/1/71.short
4100  - http://svn.bmj.com/content/7/1/71.full
SO  - Stroke Vasc Neurol2022 Feb 01; 7
AB  - Background and purpose Tenecteplase (TNK) is a promising agent for treatment of acute ischaemic stroke (AIS). We hypothesised that recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) is non-inferior to rt-PA in achieving excellent functional outcome at 90 days, when administered within 4.5 hours of ischaemic stroke onset.Methods and design Tenecteplase Reperfusion therapy in Acute ischemic Cerebrovascular Events (TRACE) is a phase III, multicentre, prospective, randomised, open-label, blinded-end point non-inferiority study. Patients eligible for intravenous thrombolysis therapy are randomised to rhTNK-tPA 0.25 mg/kg (single bolus) to a maximum of 25 mg or rt-PA 0.9 mg/kg (10% bolus+90% infusion/1 hour) to a maximum of 90 mg. Medications considered necessary for the patient’s health may be given at the discretion of the investigator during 90-day follow-up.Study outcomes The primary study outcome is excellent functional outcome defined as modified Rankin Scale (mRS) 0–1 at 90 days. Secondary efficacy outcomes include favourable functional outcome defined as mRS ≤2 at 90 days, ordinal distribution of mRS and major neurological improvement on the National Institutes of Health Stroke Scale. Safety outcomes are symptomatic intracranial haemorrhage within 36 hours and death from any cause.Discussion There is no completed registration study of TNK in AIS worldwide. TRACE II strives to provide evidence for a new drug application for rhTNK-tPA in AIS within 4.5 hours through a well-designed and rigorously executed randomised trial in China.Trial registration number NCT04797013.Data are available on reasonable request. None.