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

Journal: BMJ neurology open

Volume: 6

Issue: 1

Year of Publication: 

Affiliated Institutions:  Department of Neurology, All India Institute of Medical Sciences, New Delhi, India. Department of Neuroimaging and Interventional Neuroradiology, All India Institute of Medical Sciences, New Delhi, India. Department of Neurology, Christian Medical College, Ludhiana, India. Department of Neurology, Post Graduate Institute of Medical Education & Research, Chandigarh, India. Department of Neurology, Sree Chitra Tirunal Institute of Medical Sciences & Technology, Thiruvananthapuram, India. Department of Neurology, Christian Medical College, Vellore, India. Department of Neurology, Lalitha Superspeciality Hospital, Guntur, India. Department of Neurology, National Institute of Mental Health and Neurosciences, Bangalore, India. Department of Neurology, Institute of Neurosciences, Kolkata, India. Department of Neurology, Bangur Institute of Neurosciences and IPGMER, Kolkata, India. Department of Neurology, Amrita Institute of Medical Sciences, Kochi, India. Department of Neurology, Aster MIMS, Calicut, India. Indian Council of Medical Research, New Delhi, India.

Abstract summary 

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.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.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.This study is a prospective, randomised, multicentre, open-label trial with blinded outcome analysis design.The 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. 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. include any intracranial bleeding or symptomatic ICH.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.CTRI/2022/01/039473.

Authors & Co-authors:  Bhatia Srivastava Fatima Sarkar Longkumer Gaikwad Devaranjan Garg Durai Pandian Khurana Sylaja Jain Arora Dhasan Aaron Miraclin Vijaya Rajendran Roy Ray Nambiar Alapatt Sharma

Study Outcome 

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Statistics
Citations :  Huang X, MacIsaac R, Thompson JL, et al. . Tenecteplase versus alteplase in stroke thrombolysis: an individual patient data meta-analysis of randomized controlled trials. Int J Stroke 2016;11:534–43. 10.1177/1747493016641112
Authors :  23
Identifiers
Doi : e000531
SSN : 2632-6140
Study Population
Male,Female
Mesh Terms
Other Terms
cerebrovascular disease;endovascular treatment (EVT);large vessel occlusion (LVO);stroke;thrombolysis
Study Design
Study Approach
Country of Study
Publication Country
England