INSTRuCT

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.

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

“…The trial started in September 2022, and is expected to be completed by August 2025, corresponding to a total duration of 36 months. There are 12 study sites across the country which are part of the Indian Stroke Clinical Trial Network (INSTRuCT) collaborative sites 6. The protocol has been written in accordance with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.…”

Protocol of Process Evaluation of Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India (SPRINT INDIA)Trial

“…The INSTRuCT Network, CCC comprises of JDP, the Principal Investigator (PI) with Information Technology (IT) personnel, two National Coordinators (SJV and DA), one Statistician and Research Associate (AD). (Pandian et al, 2021). The primary responsibility of the PE will lie with SJV.…”

“…The main results of the SPRINT India PE will be published by approval from the INSTRuCT Steering Committee with appropriate authorship determined by the steering committee and as per International Committee of Medical Journal Editors (Pandian et al, 2021). The corresponding author would specify the chosen citation, correctly identify all individual authors and list additional group members in the acknowledgements (Pandian et al, 2021).…”

“…'Secondary Prevention By Structured Semi-Interactive Stroke Prevention Package in India (SPRINT INDIA)' trial was the first trial to be initiated in 2017 in the Indian Stroke Clinical Trial Network (INSTRuCT) established under the aegis of Indian Council of Medical Research. (Pandian et al, 2021). SPRINT India is a randomised controlled trial, parallel design, adaptive and blinded end-point clinical trial of subacute stroke patients initiated with the aim to reduce recurrent stroke, acute coronary syndrome and deaths in patients (Kate et al, 2020).…”

Adaptive trials in stroke: Current use & future directions

“…With growing uptake of adaptive features (Table 1), it is important to consider the role of professional organisations (e.g., World Stroke Organisation, European Stroke Organisation) and networks (e.g., CanStroke Recovery Trials, Canadian Stroke Consortium, Australasian Stroke Trials Network, NIH StrokeNet 48 , Global Alliance of Independent Networks focused on Stroke trials (GAINS), Indian Stroke Clinical Trial Network (INSTRuCT 49 )), European Stroke Organsiation Trial Alliance (ESOTA 50 )) to prepare current and future generations of clinical trialists to embrace, where appropriate, adaptive trial designs. Clinical trial stakeholders have identified that broadening the acceptance and uptake of adaptive trials will depend on access to training, guidelines, and toolkits to ensure proper use of adaptive trial designs in practice 51 .…”