Impact, Cost, and Sustainability of a Customized, Low-Cost Intervention to Reduce Cardiovascular Disease Burden in India: A Cluster Randomized Trial

The ICRAG-2 project aims to assess the impact, cost-effectiveness, and sustainability of a low-cost, multipronged intervention package to reduce cardiovascular disease (CVD) burden in India. Given the high CVD mortality rate in India, this study addresses the urgent need for scalable, evidence-based solutions. The project will unfold in three steps: first, formative research including systematic reviews, cross-sectional studies, and qualitative studies will identify key barriers, facilitators, and refine interventions. Next, a matched-pair cluster randomized controlled trial (CRCT) across 26 clusters will evaluate the intervention's impact on CVD outcomes over three years, focusing on therapeutic lifestyle changes, fixed-dose medications, and task-sharing with non-physician health workers. Finally, the project will engage stakeholders through policy dialogues to support potential national-scale implementation. This trial offers a promising model to reduce CVD incidence through customized, sustainable interventions targeting patients, providers, and the health system.

NCT Number	NCT06836661
Lead Sponsor	St. John's Research Institute Collaborators: Assam Medical College, Dibrugarh, India, SRM Medical College Hospital & Research Centre, Jawaharlal Institute of Postgraduate Medical Education & Research, Indian Council of Medical Research, All India Institute of Medical Sciences, Bhopal
Conditions	ST Elevation (STEMI) Myocardial Infarction of Anterior Wall, Cardiovascular Diseases
Enrollment	1,560 participants
Start Date	2025-06-01
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-05-18