INSTRuCT

Author:

Pandian Jeyaraj Durai1ORCID,Verma Shweta Jain1,Arora Deepti1ORCID,Sharma Meenakshi2,Dhaliwal Rupinder2,Khatter Himani1,Huilgol Rahul1,Sylaja P.N.3,Dhasan Aneesh3ORCID,Renjith Vishnu3ORCID,Pathak Abhishek4,Pai Aparna5,Sharma Arvind6,Vaishnav Anand7ORCID,Ray Biman8ORCID,Khurana Dheeraj9,Mittal Gaurav10ORCID,Kulkarni Girish11,Sebastian Ivy10,Roy Jayanta12,Kumaravelu Somasundaram13ORCID,John Lydia14,Kate Mahesh1ORCID,Srivastava M.V.15ORCID,Kempegowda Madhusudhan Byadarahalli16,Borah Nomal17,Ramrakhiani Neetu18,Rai Nirendra19,Ojha Pawan20,Bhatia Rohit15ORCID,Das Rupjyoti17,Sureshbabu Sachin10,Jabeen Shaikh Afshan21,Bhoi Sanjeev22,Aaron Sanjith23,Sarma Prabhakaran24ORCID,Saroja Aralikatte Onkarappa25ORCID,Abraham Sherly14,Sharma Sudhir26,Sulena Sulena27,Gorthi Sankar5,Nagarjunakonda Sundarachary28,Narayan Sunil29,Mathew Thomas30,George Tina23,Vijaya Pamidimukkala31,Huded Vikram32,Nambiar Vivek33,Reddy Y. Muralidhar34ORCID

Affiliation:

1. Department of Neurology (J.D.P., S.J.V., D.A., H.K., R.H., M.K.), Christian Medical College, Ludhiana, Punjab, India.

2. Non-Communicable Diseases Section, Indian Council of Medical Research, New Delhi, India (M.S., R. Dhaliwal).

3. Department of Neurology (P.N.S., A.D., V.R.), Sri Chitra Tirunal Institute of Medical Sciences and Technology, Thiruvananthapuram, Kerala, India.

4. Department of Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India (A. Pathak).

5. Department of Neurology, Kasturba Medical College and Hospital, Manipal, Karnataka, India (A. Pai, S.G.).

6. Department of Neurology, Zydus Hospital, Ahmedabad, Gujarat, India (A.S.).

7. Vadodara Institute of Neurosciences, Vadodara, Gujarat, India (A.V.).

8. Bangur Institute of Neurosciences, Kolkata, India (B.R.).

9. Department of Neurology, Post Graduate Institute of Medical Education and Research, Chandigarh, India (D.K.).

10. Department of Neurology, St Stephens Hospital, Delhi, India (G.M., I.S., S. Sureshbabu).

11. Department of Neurology, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, India (G.K.).

12. Department of Neurology, Institute of Neurosciences, Kolkata, West Bengal, India (J.R.).

13. Department of Neurology, Ramesh Hospital, Guntur, Andhra Pradesh, India (S.K.).

14. Department of Medicine, Baptist Christian Hospital, Tezpur, Assam, India (L.J., S. Abraham).

15. Department of Neurology, All India Institute of Medical Sciences, New Delhi, India (M.V.S., R.B.).

16. Department of Neurology, BGS Global Hospital, Bangalore, Karnataka, India (M.B.K.).

17. Department of Neurology, Guwahati Neurological Research Centre, Dispur, India (N.B., R. Das).

18. Department of Neurology, Fortis Escorts Hospital, Jaipur, Rajasthan, India (N. Ramrakhiani).

19. Department of Neurology, All India Institute of Medical Sciences, Bhopal, Madhya Pradesh, India (N. Rai).

20. Department of Neurology, Grant Government Medical College and Sir J.J. Group of Hospitals College, Mumbai, India (P.O.).

21. Department of Neurology, Nizam’s Institute of Medical Sciences, Hyderabad, Telangana, India (S.A.J.).

22. Department of Neurology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India (S.B.).

23. Department of Neurology, Christian Medical College, Vellore, Tamil Nadu, India (S. Aaron, T.G.)

24. Achutha Menon Center for Health Science Studies (P.S.), Sri Chitra Tirunal Institute of Medical Sciences and Technology, Thiruvananthapuram, Kerala, India.

25. Department of Neurology, KLE Academy of Higher Education & Research, Belagavi, Karnataka, India (A.O.S.).

26. Department of Neurology, Indira Gandhi Medical College & Hospital, Shimla, Himachal Pradesh, India (S. Sharma).

27. Department of Neurology, GGS Medical College, Faridkot, Punjab, India (S. Sulena).

28. Department of Neurology, Government General Hospital, Guntur, Andhra Pradesh, India (S. Nagarjunakonda).

29. Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India (S. Narayan).

30. Department of Neurology, St John’s Medical College, Bangalore, Karnataka, India (T.M.).

31. Department of Neurology, Lalitha Super Speciality Hospital, Guntur, Andhra Pradesh, India (P.V.).

32. Department of Neurology, Mazumdar Shaw Medical Centre, Narayana Hrudayalaya, Bangalore, Karnataka, India (V.H.).

33. Department of Neurology, Amrita Institute of Medical Sciences, Kochi, Kerala, India (V.N.).

34. Department of Neurology, CARE Hospital, Hyderabad, Telangana, India (M.R.).

Abstract

Background and Purpose: Very few large scale multicentric stroke clinical trials have been done in India. The Indian Council of Medical Research funded INSTRuCT (Indian Stroke Clinical Trial Network) as a task force project with the objectives to establish a state-of-the-art stroke clinical trial network and to conduct pharmacological and nonpharmacological stroke clinical trials relevant to the nation and globally. The purpose of the article is to enumerate the structure of multicentric stroke network, with emphasis on its scope, challenges and expectations in India. Methods: Multiple expert group meetings were conducted by Indian Council of Medical Research to understand the scope of network to perform stroke clinical trials in the country. Established stroke centers with annual volume of 200 patients with stroke with prior experience of conducting clinical trials were included. Central coordinating center, standard operating procedures, data and safety monitoring board were formed. Discussion: In first phase, 2 trials were initiated namely, SPRINT (Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India) and Ayurveda treatment in the rehabilitation of patients with ischemic stroke in India (RESTORE [Rehabilitation of Ischemic stroke Patients in India: A Randomized controlled trial]). In second phase, 4 trials have been approved. SPRINT trial was the first to be initiated. SPRINT trial randomized first patient on April 28, 2018; recruited 3048 patients with an average of 128.5 per month so far. The first follow-up was completed on May 27, 2019. RESTORE trial randomized first patient on May 22, 2019; recruited 49 patients with an average of 3.7 per month so far. The first follow-up was completed on August 30, 2019. Conclusions: In next 5 years, INSTRuCT will be able to complete high-quality large scale stroke trials which are relevant globally. REGISTRATION: URL: http://www.ctri.nic.in/ ; Unique Identifier: CTRI/2017/05/008507.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialized Nursing,Cardiology and Cardiovascular Medicine,Neurology (clinical)

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