RE-OPEN: Randomised trial of biosimilar TNK versus TPA during endovascular therapy for acute ischaemic stroke due to large vessel occlusions.

Autor:	Bhatia R; Department of Neurology, All India Institute of Medical Sciences, New Delhi, India., Srivastava MP; Department of Neurology, All India Institute of Medical Sciences, New Delhi, India., Fatima S; Department of Neurology, All India Institute of Medical Sciences, New Delhi, India., Sarkar R; Department of Neurology, All India Institute of Medical Sciences, New Delhi, India., Longkumer I; Department of Neurology, All India Institute of Medical Sciences, New Delhi, India., Gaikwad S; Department of Neuroimaging and Interventional Neuroradiology, All India Institute of Medical Sciences, New Delhi, India., Devaranjan LSJ; Department of Neuroimaging and Interventional Neuroradiology, All India Institute of Medical Sciences, New Delhi, India., Garg A; Department of Neuroimaging and Interventional Neuroradiology, All India Institute of Medical Sciences, New Delhi, India., Durai Pandian J; Department of Neurology, Christian Medical College, Ludhiana, India., Khurana D; Department of Neurology, Post Graduate Institute of Medical Education & Research, Chandigarh, India., Sylaja PN; Department of Neurology, Sree Chitra Tirunal Institute of Medical Sciences & Technology, Thiruvananthapuram, India., Jain S; Department of Neurology, Christian Medical College, Ludhiana, India., Arora D; Department of Neurology, Christian Medical College, Ludhiana, India., Dhasan A; Department of Neurology, Sree Chitra Tirunal Institute of Medical Sciences & Technology, Thiruvananthapuram, India., Aaron S; Department of Neurology, Christian Medical College, Vellore, India., Miraclin AT; Department of Neurology, Christian Medical College, Vellore, India., Vijaya P; Department of Neurology, Lalitha Superspeciality Hospital, Guntur, India., Rajendran SP; Department of Neurology, National Institute of Mental Health and Neurosciences, Bangalore, India., Roy J; Department of Neurology, Institute of Neurosciences, Kolkata, India., Ray BK; Department of Neurology, Bangur Institute of Neurosciences and IPGMER, Kolkata, India., Nambiar V; Department of Neurology, Amrita Institute of Medical Sciences, Kochi, India., Alapatt PJ; Department of Neurology, Aster MIMS, Calicut, India., Sharma M; Indian Council of Medical Research, New Delhi, India.
Jazyk:	angličtina
Zdroj:	BMJ neurology open [BMJ Neurol Open] 2024 Mar 15; Vol. 6 (1), pp. e000531. Date of Electronic Publication: 2024 Mar 15 (Print Publication: 2024).
DOI:	10.1136/bmjno-2023-000531
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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