RT Journal Article
SR Electronic
T1 Reteplase versus alteplase for acute ischaemic stroke within 4.5 hours (RAISE): rationale and design of a multicentre, prospective, randomised, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP 568
OP 573
DO 10.1136/svn-2023-003035
VO 9
IS 5
A1 Li, Shuya
A1 Gu, Hong-Qiu
A1 Dai, Hongguo
A1 Lu, Guozhi
A1 Wang, Yongjun
YR 2024
UL http://svn.bmj.com/content/9/5/568.abstract
AB Background and purpose Reteplase is the third generation of alternative thrombolytic agent. We hypothesis that reteplase will be non-inferior to alteplase in achieving excellent functional outcome at 90 days among eligible patients with acute ischaemic stroke.Methods and design Reteplase versus alteplase for acute ischaemic stroke within 4.5 hours (RAISE) trial is a multicentre, prospective, randomised, open-label, blinded endpoint (PROBE), controlled phase 3 non-inferiority trial. A total of 1412 eligible patients will be randomly assigned to receive either reteplase at a dose of 18 mg+ 18 mg or alteplase 0.9 mg/kg at a ratio of 1:1. An independent data monitoring committee will review the trail’s progress and safety data.Study outcomes The primary efficacy outcome of this study is proportion of individuals attaining an excellent functional outcome, defined as modified Rankin Scale (mRS) 0–1 at 90 days. The secondary efficacy outcomes encompass favourable functional outcome defined as mRS 0–2, major neurological improvement on the National Institutes of Health Stroke Scale, ordinal distribution of mRS and Barthel Index score of at least 95 points at 90 days. The primary safety outcomes are symptomatic intracranial haemorrhage at 36 hours within 90 days.Discussion The RAISE trial will provide crucial insights into the selection of thrombolytic agents for stroke thrombolysis.Trial registration number NCT05295173.Data sharing not applicable as no data sets generated and/or analysed for this study.