BMJ Neurology Open (Mar 2024)
RE-OPEN: Randomised trial of biosimilar TNK versus TPA during endovascular therapy for acute ischaemic stroke due to large vessel occlusions
- ,
- 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
Affiliations
- 30Dept. of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, India
- Deepti Vibha
- Department of Neurology, All India Institute of Medical Sciences, New Delhi, Delhi, India
- Rajesh Kumar Singh
- 3 Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
- Rohit Bhatia
- Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
- Ayush Agarwal
- Neurology, All India Institute of Medical Sciences, New Delhi, India
- Shweta Jain
- Department of Neurology, Christian Medical College, Ludhiana, India
- Dheeraj Khurana
- Neurology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
- Deep Das
- Department of Neurology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India
- Biman Kanti Ray
- Neurology, Institute of Postgraduate Medical Education and Research, Bangur Institute of Neurosciences, Kolkata, West Bengal, India
- Deepti Arora
- Max Super Speciality Hospital, Delhi, India
- Meenakshi Sharma
- Centre for Public Health, Queen`s University Belfast, Belfast, UK
- Ajay Garg
- Department of Neuroimaging and Interventional Neuroradiology, All India Institute of Medical Sciences, New Delhi, India
- Pamidimukkala Vijaya
- Stroke Unit, Department of Neurology, Brain and Heart Centre, Guntur, Andhra Pradesh, India
- Vivek Nambiar
- 1Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada
- Girish Baburao Kulkarni
- Department of Neurology, National Institute of Mental Health and Neuro Sciences, Bangalore, Karnataka, India
- Sanjith Aaron
- Department of Neurosciences, Christian Medical College Vellore, Vellore, Tamil Nadu, India
- Angel T Miraclin
- Department of Neurosciences, Christian Medical College Vellore, Vellore, Tamil Nadu, India
- PN Sylaja
- Department of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India
- MV Padma Srivastava
- Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
- Saman Fatima
- Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
- Risha Sarkar
- Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
- Imnameren Longkumer
- Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
- Shailesh Gaikwad
- Department of Neuroimaging and Interventional Neuroradiology, All India Institute of Medical Sciences, New Delhi, India
- Leve S Joseph Devaranjan
- Department of Neuroimaging and Interventional Neuroradiology, All India Institute of Medical Sciences, New Delhi, India
- Jeyaraj Durai Pandian
- Department of Neurology, Christian Medical College, Ludhiana, India
- Aneesh Dhasan
- Department of Neurology, Sree Chitra Tirunal Institute of Medical Sciences & Technology, Thiruvananthapuram, India
- Srijithesh P Rajendran
- Department of Neurology, National Institute of Mental Health and Neurosciences, Bangalore, India
- Jayanta Roy
- Department of Neurology, Institute of Neurosciences, Kolkata, India
- Paul J Alapatt
- Department of Neurology, Aster MIMS, Calicut, India
- 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
- DOI
- https://doi.org/10.1136/bmjno-2023-000531
- Journal volume & issue
-
Vol. 6,
no. 1
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.
