The Indian Stroke Clinical Trial Network has been created to conduct small and large clinical trials and research studies to advance acute stroke treatment, stroke prevention, and recovery and rehabilitation following a stroke. This network of 24 regional centers across India involves 25 hospitals and is designed to serve as the infrastructure and pipeline for exciting new potential treatments for patients with stroke and those at risk for stroke. In addition, INSTRuCT will provide an educational platform for stroke physicians and clinical trial coordinators.
The INSTRuCT Network has been established as a Task Focre Research Project under the aegis of the Indian Council of Medical Research. The ICMR, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest and largest medical research bodies in the world. The ICMR is funded by the Government of India through the Department of Health Research, Ministry of Health and Family Welfare.
To begin with the INSTRuCT network will focus on stroke clinical trials a minimum of 4-5 in the area of acute stroke, secondary prevention and rehabilitation. INSTRUcT will collaborate with professional, industry, academic and funding bodies (within and outside the country) to enhance and increase Indian stroke clinical trials.
Enhanced Control of Hypertension and Thrombolysis Stroke study (ENCHANTED) Funded by NHRMC, Australia. ENCHANTED was an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative treatment arms, which aimed to address 4 key questions in patients eligible for thrombolysis in the hyperacute phase of ischaemic stroke. Worldwide, 2227 patients were recruited between March 2017 and April 2018. Of these 35 were contributed from India from 15 centres of the INSTRuCT Network.
Results: The BP intensive lowering arm ( < 140 mm Hg) was not shown to be superior to guideline recommended BP lowering (< 180 mm Hg) for primary disability outcome. The results have been published in the Lancet.
The Secondary Prevention By Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA) Trial will be carried out to assess the role of a structured semi-interactive stroke prevention package to reduce the risk of recurrent strokes, myocardial infarction and death in patients with sub-acute stroke after one month.
AyuRvedic TrEatment in the Rehabilitation of IschemicSTrOke Patients in India: A Randomized controllEd trial (RESTORE) for a) finding out the safety and efficacy of Ayurvedic treatment in the rehabilitation of stroke patients b) comparing the efficacy of Ayurvedic treatment over conventional physiotherapy in the rehabilitation of stroke patients.