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

NCT06836661 · tracked via the Priya Life Science India tracker

Sponsor

St. John's Research Institute

Phase

N/A

Started

2025-06-01

Last updated

2025-05-18

Condition(s) studied

ST Elevation (STEMI) Myocardial Infarction of Anterior WallCardiovascular Diseases

Investigational drug(s) / intervention(s)

FDC and TLC and medication adherancePatients will Enhanced Usual Care (EUC)

FDC and TLC and medication adherance: Level 1: Patient 1. Rational FDCs 2. NPHWs and PMs mediated therapeutic lifestyle changes 3. Texts/ WhatsApp reminders Level 2:Physician 1. Reinforcing task sharing 2. Providing evidence on FDCs 3. Theory based behavior modification Level 3: Health administrators 1. Pharmacy - Update drug formulary FDCs 2. CV health days 3. Facility strengthening

Patients will Enhanced Usual Care (EUC): Patients will Enhanced Usual Care (EUC) with periodic follow ups

Study summary

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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

99 Years

Healthy volunteers

Inclusion Criteria: \- 1. High-risk primary prevention A. Patients aged more than 40years of any gender without a CVD event (MI, Stroke) with at least two of the following risk factors, A to E with a 10 year documented evidence OF (a to d) a. Diabetes Mellitus b. Hypertension c. Dyslipidaemia d. Microalbuminuria e. Family history of premature CVD event (MI, stroke or CVD-related death under 55 years) B. Patients aged above 50years of any gender without a CVD event (MI, Stroke) with at least one year of documented disease, at least two A to D (Above) 2. High-risk secondary prevention Patients aged above 40 years or above, with a CVD event with any one of the following: options a. MI or stroke less than three months, \<br/\> b. MI or stroke, more than three months, but less than one year with at least one comorbid condition, that is A to E (Above). c. Patients aged above 60 years or above with MI or stroke greater than three months BUT less than one year, without any comorbid condition. These patients are expected to have a moderate to high risk of a CVD event or death in the next three years. Exclusion Criteria: * We will exclude patients with any ONE of the following: 1. Severe cognitive impairment of any aetiology and have no reliable caregivers. 2. Medical conditions with a survival prognosis of less than 12 months. 3. Unable to follow-up for the study period

Primary outcome measure(s)

Composite of death, myocardial infarction, stroke and CVD-related hospitalisations at three years — 3 years

Trial sites (1)

Facility	City	Region	Status
Division of Clinical Research and training St. John's Research Institute Koramangala , - , India	Bangalore	Karnataka

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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