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INSTRuCT: Protocol, Infrastructure, and Governance.

Jeyaraj Durai Pandian1, Shweta Jain Verma1, Deepti Arora1

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

Stroke
|June 25, 2021
PubMed
Summary
This summary is machine-generated.

The Indian Stroke Clinical Trial Network (INSTRuCT) was established to conduct large-scale stroke clinical trials in India. This network aims to deliver high-quality, globally relevant stroke research within five years.

Keywords:
incidenceischemic strokenetworkresearchsecondary preventionstroke trialstechnology

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Area of Science:

  • Neurology
  • Clinical Trials
  • Public Health

Background:

  • Limited large-scale, multicentric stroke clinical trials have been conducted in India.
  • The Indian Council of Medical Research established the Indian Stroke Clinical Trial Network (INSTRuCT) as a task force project.
  • INSTRuCT aims to create a state-of-the-art network for stroke clinical trials.

Purpose of the Study:

  • To establish a robust multicentric stroke clinical trial network in India.
  • To conduct pharmacological and non-pharmacological stroke clinical trials relevant to national and global needs.
  • To outline the structure, scope, challenges, and expectations of this stroke network.

Main Methods:

  • Expert group meetings were convened by the Indian Council of Medical Research to define the network's scope.
  • Stroke centers with a minimum annual volume of 200 stroke patients and prior trial experience were included.
  • A central coordinating center, standard operating procedures, and a data and safety monitoring board were established.

Main Results:

  • The first phase initiated two trials: SPRINT (Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India) and RESTORE (Rehabilitation of Ischemic stroke Patients in India).
  • The SPRINT trial randomized its first patient in April 2018 and has since recruited 3048 patients.
  • The RESTORE trial randomized its first patient in May 2019, recruiting 49 patients to date.

Conclusions:

  • INSTRuCT is positioned to complete high-quality, large-scale stroke trials with global relevance in the next five years.
  • The network's structure and initial trials demonstrate progress in advancing stroke research in India.