RT Journal Article
SR Electronic
T1 Treatment with intravenous alteplase in ischaemic stroke patients with onset time between 4.5 and 24 hours (HOPE): protocol for a randomised, controlled, multicentre study
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP svn-2022-002154
DO 10.1136/svn-2022-002154
A1 Luo, Zhongyu
A1 Zhou, Ying
A1 He, Yaode
A1 Yan, Shenqiang
A1 Chen, Zhicai
A1 Zhang, Xuting
A1 Chen, Yi
A1 Tong, Lu-Sha
A1 Zhong, Wansi
A1 Hu, Haitao
A1 Zhang, Kemeng
A1 Yang, Jiansheng
A1 Campbell, Bruce C V
A1 Lou, Min
YR 2023
UL http://svn.bmj.com/content/early/2023/08/01/svn-2022-002154.abstract
AB Background While intravenous thrombolysis is recommended for patients who had an acute ischaemic stroke (AIS) within 4.5 hours of symptom onset, there are few randomised trials investigating the benefits of thrombolysis beyond this therapeutic window.Aim To determine whether patients who had an AIS selected with the presence of potentially salvageable tissue on CT perfusion at 4.5–24 hours after stroke onset (for stroke with unknown onset time, the midpoint of the time last known to be well and symptom recognition time; for wake-up stroke, the midpoint of the time last known to be well or sleep onset and wake up time) will benefit from intravenous thrombolysis.Design HOPE is a prospective, multicentre, randomised, open-label blinded endpoint trial with the stage of phase III. The treatment allocation employs 1:1 randomisation. The treatment arm under investigation is alteplase with standard therapy, the control arm is standard therapy. Eligibility imaging criteria include ischaemic core volume ≤70 mL, penumbra ≥10 mL and mismatch ≥20%.Study outcomes The primary outcome is non-disabled functional outcome (assessed as modified Rankin Scale score of 0–1 at 90 days).Discussion HOPE is the first trial to investigate whether intravenous thrombolysis with alteplase offers benefits in patients who had an AIS presenting within 4.5–24 hours, which has the potential to extend time window and expand eligible population for thrombolysis therapy.The dataset is available from the corresponding author on reasonable request.