학술논문
RE-OPEN: Randomised trial of biosimilar TNK versus TPA during endovascular therapy for acute ischaemic stroke due to large vessel occlusions
Document Type
article
Author
Deepti Vibha; Rajesh Kumar Singh; Rohit Bhatia; Ayush Agarwal; Shweta Jain; Dheeraj Khurana; Deep Das; Biman Kanti Ray; Deepti Arora; Meenakshi Sharma; Ajay Garg; Pamidimukkala Vijaya; Vivek Nambiar; Girish Baburao Kulkarni; Sanjith Aaron; Angel T Miraclin; PN Sylaja; MV Padma Srivastava; Saman Fatima; Risha Sarkar; Imnameren Longkumer; Shailesh Gaikwad; Leve S Joseph Devaranjan; Jeyaraj Durai Pandian; Aneesh Dhasan; Srijithesh P Rajendran; Jayanta Roy; Paul J Alapatt; Awadh K Pandit; Venugopalan Y Vishnu; Rajeshwar Sahonta; Rahul Huilgol; KS Arya Devi; Chirag Ahuja; Pheba Susan Raju; ER Jayadevan; Sapna Erat Sreedharan; K Santhosh Kumar; K Sajith; KP Abdurehiman; LK Sreevidya; Subhadeep Banerjee; Srinivas Reddy; Pritam Raja; RS Dhaliwal
Source
BMJ Neurology Open, Vol 6, Iss 1 (2024)
Subject
Language
English
ISSN
2632-6140
Abstract
Rationale Rapid and timely treatment with intravenous thrombolysis and endovascular treatment (EVT) in patients with acute ischaemic stroke (AIS) and large vessel occlusion (LVO) significantly improves patient outcomes. Bridging therapy is the current standard of care in these patients. However, an incompletely answered question is whether one thrombolytic agent is better than another during bridging therapy.Aim The current study aims to understand if one thrombolytic agent is superior to the other during bridging therapy in the treatment of AIS and LVO.Sample size estimates Using 80% power and an alpha error of 5 %, presuming a 10% drop out rate, a total of 372 patients will be recruited for the study.Methods and design This study is a prospective, randomised, multicentre, open-label trial with blinded outcome analysis design.Study outcomes The primary outcomes include proportion of patients who will be independent at 3 months (modified Rankin score (mRS) ≤2 as good outcome) and proportion of patients who achieve recanalisation modified thrombolysis in cerebral infarction grade 2b/3 at first angiography run at the end of EVT. Secondary outcomes include proportion of patients with early neurological improvement, rate of symptomatic intracerebral haemorrhage (ICH), rate of any ICH, rate of any systemic major or minor bleeding and duration of hospital stay. Safety outcomes include any intracranial bleeding or symptomatic ICH.Discussion This trial is envisioned to confirm the theoretical advantages and increase the strength and quality of evidence for use of tenecteplase (TNK) in practice. Also, it will help to generate data on the efficacy and safety of biosimilar TNK.Trial registration number CTRI/2022/01/039473.