NCT06836661Not yet recruiting
Impact, Cost, and Sustainability of a Customized, Low-Cost Intervention to Reduce Cardiovascular Disease Burden in India: A Cluster Randomized Trial
Effect, Cost, and sustaiNability of a Synergistic, Multipronged, Customized, Low-cost Intervention Package to Reduce cArdiovascular Burden Across India: a cLustEr RCT
Source: ClinicalTrials.gov · Last updated 18 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1560 (estimated)
- First submitted
- 1 Feb 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- St. John's Research Institute
- Diseases
- Coronary artery disease
- NCT number
- NCT06836661
What you commit to
- Study type: Interventional
- Planned participants: 1560
- From 1 Jun 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- We will exclude patients with any ONE of the following:
- Severe cognitive impairment of any aetiology and have no reliable caregivers.
- Medical conditions with a survival prognosis of less than 12 months.
- Unable to follow-up for the study period
Who the study is looking for
- \- 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).
- 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.
Age in the registry: 40 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Clinical Research and training St. John's Research Institute Koramangala , - , India Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.