BMJ Neurology Open (Mar 2024)
STENOSIS: Long-term single versus dual antiplatelet therapy in patients with ischaemic stroke due to intracranial atherosclerotic disease – a randomised trial
- Ashish Sharma,
- Thomas Iype,
- Deepti Vibha,
- Jeyaraj Durai Pandian,
- Rajesh Kumar Singh,
- Rajinder K Dhamija,
- Rohit Bhatia,
- Ayush Agarwal,
- Shweta Jain,
- Dheeraj Khurana,
- Sudhir Sharma,
- Shyam K Jaiswal,
- Biman Kanti Ray,
- Sunil K Narayan,
- Deepti Arora,
- Meenakshi Sharma,
- Ajay Garg,
- Pamidimukkala Vijaya,
- Vivek Nambiar,
- Rajsrinivas Parthasarathy,
- Pooja Gupta,
- Girish Baburao Kulkarni,
- Sanjith Aaron,
- Deepti Bal,
- PN Sylaja,
- Arvind Sharma,
- MV Padma Srivastava,
- Saman Fatima,
- Risha Sarkar,
- Imnameren Longkumer,
- Aneesh Dhasan,
- Srijithesh P Rajendran,
- Jayanta Roy,
- Paul J Alapatt,
- Awadh K Pandit,
- Venugopalan Y Vishnu,
- Rahul Huilgol,
- KS Arya Devi,
- Pheba Susan Raju,
- RS Dhaliwal,
- Sanjeev Kumar Bhoi,
- Binod Sarmah,
- SP Gorthi,
- Somasundaram Kumaravelu,
- Lakshya Jyoti Basumatary,
- Neetu Ramrakhiani,
- Rupjyoti Das,
- NV Sundarachary,
- Vijay Sardana,
- Chithra Mukesh,
- Sulena Sulena,
- Abhishek Pathak,
- T Harisuthan,
- Aparna R Pai,
- TCR Ramakrishnan,
- AO Saroja,
- Ravishankar Naik,
- Neeraj Bhutani,
- Soaham Desai,
- Gaurav Kumar Mittal,
- S Saravanan,
- Leve S Joseph Devaranjan
Affiliations
- Ashish Sharma
- RD Gardi Medical College, Ujjain, India
- Thomas Iype
- 2 Department of Neurology, Government Medical College, Thiruvananthapuram, Kerala, India
- Deepti Vibha
- Department of Neurology, All India Institute of Medical Sciences, New Delhi, Delhi, India
- Jeyaraj Durai Pandian
- Department of Neurology, Christian Medical College & Hospital Ludhiana, Ludhiana, India
- Rajesh Kumar Singh
- 3 Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
- Rajinder K Dhamija
- Institute of Human Behaviour and Allied Sciences, New Delhi, Delhi, India
- Rohit Bhatia
- Neurology, AIIMS, New Delhi, India
- Ayush Agarwal
- Neurology, All India Institute of Medical Sciences, New Delhi, India
- Shweta Jain
- 1Seattle Genetics, Inc., Bothell, USA
- Dheeraj Khurana
- Neurology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
- Sudhir Sharma
- Department of Neurology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India
- Shyam K Jaiswal
- Neurology, CARE Hospitals - Banjara Hills, Hyderabad, Telangana, India
- Biman Kanti Ray
- Neurology, Institute of Postgraduate Medical Education and Research, Bangur Institute of Neurosciences, Kolkata, West Bengal, India
- Sunil K Narayan
- Neurology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India
- Deepti Arora
- Max Super Speciality Hospital, Delhi, India
- Meenakshi Sharma
- Centre for Public Health, Queen`s University Belfast, Belfast, UK
- Ajay Garg
- 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
- Rajsrinivas Parthasarathy
- 1 Department of Neurointerventional Surgery, Artemis Hospitals, Sector 51, Gurgaon, Haryana-122001
- Pooja Gupta
- Department of Dermatology and STD, University College of Medical Sciences and GTB Hospital, University of Delhi, India
- 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
- Deepti Bal
- Department of Neurological Sciences, Christian Medical College, Vellore, Tamil Nadu, India
- PN Sylaja
- Department of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India
- Arvind Sharma
- Department of Neurology, Zydus Research Center, Ahmedabad, Gujarat, 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
- 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
- Rahul Huilgol
- KS Arya Devi
- Pheba Susan Raju
- RS Dhaliwal
- Sanjeev Kumar Bhoi
- Binod Sarmah
- SP Gorthi
- Somasundaram Kumaravelu
- Lakshya Jyoti Basumatary
- Neetu Ramrakhiani
- Rupjyoti Das
- NV Sundarachary
- Vijay Sardana
- Chithra Mukesh
- Sulena Sulena
- Abhishek Pathak
- T Harisuthan
- Aparna R Pai
- TCR Ramakrishnan
- AO Saroja
- Ravishankar Naik
- Neeraj Bhutani
- Soaham Desai
- Gaurav Kumar Mittal
- S Saravanan
- Leve S Joseph Devaranjan
- DOI
- https://doi.org/10.1136/bmjno-2023-000532
- Journal volume & issue
-
Vol. 6,
no. 1
Abstract
Rationale Intracranial atherosclerotic disease (ICAD) is a pathological process that causes progressive stenosis and cerebral hypoperfusion, leading to stroke occurrence and recurrence around the world. The exact duration of dual antiplatelet therapy (DAPT) for ICAD is unclear in view of long-term risk of bleeding complications.Aim The current study aims to study the efficacy and safety of long-term DAPT (up to 12 months) in patients with ICAD.Sample size Using 80% power and an alpha error of 5 %, presuming a 10%–15% drop-out rate, a total of 2200 patients will be recruited for the study.Methodology This is a prospective, randomised, double-blind, placebo controlled trial.Study outcomes The primary outcomes include recurrent ischaemic stroke (IS) or transient ischaemic attack and any intracranial haemorrhage (ICH), major or minor systemic bleeding at the end of 12 months. Secondary outcomes include composite of any stroke, myocardial infarction or death at the end of 12 months. The safety outcomes include any ICH, major or minor bleeding as defined using GUSTO (Global Use of Streptokinase and tPA for occluded Coronary Arteries) classification at the end of 12 months and 1 month after completion of the drug treatment phase.Discussion The study will provide level I evidence on the duration of DAPT among patients with IS due to ICAD of more than or equal to 50%.
