ST Elevation (STEMI) Myocardial Infarction of Anterior WallENABLENCT06836661
Impact, Cost, and Sustainability of a Customized, Low-Cost Intervention to Reduce Cardiovascular Disease Burden in India: A Cluster Randomized Trial
A study testing FDC and TLC and medication adherance in people with ST Elevation (STEMI) Myocardial Infarction of Anterior Wall and Cardiovascular Diseases, run by St. John's Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- ST Elevation (STEMI) Myocardial Infarction of Anterior Wall, Cardiovascular Diseases
- What is being tested?
- FDC and TLC and medication adherance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,560 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2025to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Division of Clinical Research and training St. John's Research Institute Koramangala , - , India
Bangalore, Karnataka, 560034
Denis Xavier, Dr., 49466141 ext. 91-80, denis.xavier@stjohns.in
Deepa S, Dr., 49467081 ext. 91-80, deepa.sn@sjri.res.in
About this study
Official title: Effect, Cost, and sustaiNability of a Synergistic, Multipronged, Customized, Low-cost Intervention Package to Reduce cArdiovascular Burden Across India: a cLustEr RCT
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.
Read the detailed description
Cardiovascular diseases (CVD) are the leading cause of death worldwide, responsible for approximately 17.9 million deaths each year, which accounts for 31% of all global deaths. The majority of these deaths-about 85%-are due to heart attacks and strokes. In India, CVD has contributed to 28·1% of the total deaths and 14·1% of the total DALYs. There is a remarkably high burden of CVD in India, with an age-standardised death rate of 282 deaths/100,000 (264-293) compared with global levels (233 deaths per 100,000 (229-236). Ischemic heart disease and stroke have been identified as the top two causes of mortality in the country, highlighting the urgent need for effective interventions.
Evidence supports the effectiveness of fixed dose combination treatments and the use of Non-Physician Health Workers (NPHWs) in primary and secondary prevention of CVD. India's healthcare system faces the dual challenge of rising CVD mortality and a lack of integrated preventive and management strategies for CVD at both the primary and secondary care levels. NPHWs play a major role in reducing CVD risk factors.
Despite the growing burden of CVD, there is a notable lack of evidence in India that evaluate comprehensive CVD management strategies across multiple levels, particularly focusing on hard clinical endpoints such as mortality, myocardial infarction (MI), stroke, and cardiovascular hospitalisations. To fill these gaps, we need a robust implementation trial that evaluates the effectiveness of multiple proven interventions in diverse settings on hard clinical endpoints. Such a trial, likely the first of its kind, would provide key evidence to guide policy decisions to improve CVD management strategies in India.
- Being tested
- FDC and TLC and medication adherance, Patients will Enhanced Usual Care (EUC)
- Keywords
- CVD, Low cost intervention, task sharing, fixed dose combination pills
- Medical subject headings
- ST Elevation Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDC and TLC and medication adheranceBehavioural
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)Behavioural
Patients will Enhanced Usual Care (EUC) with periodic follow ups
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm - FDC and TLC and medication adherance | Experimental | NPHW enabled education and counseliing along with prescribing combination therapies and TLC and availability of low cost rational FDC at hospital pharmacy Receives: Behavioral: FDC and TLC and medication adherance |
| Control arm - Patients will Enhanced Usual Care (EUC) | Experimental | Enhanced Usual Care (EUC) with periodic follow ups. Receives: Behavioral: Patients will Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of death, myocardial infarction, stroke and CVD-related hospitalisations at three years
Measured: 3 years
Secondary outcomes (1)
The Cost-Effectiveness (incremental cost- effectiveness ratio, ICER) of the IP
- The Cost-Effectiveness (incremental cost- effectiveness ratio, ICER) of the IP c) Key Fidelity Metrics - utilisation rates of fixed-dose combinations, adherence to drug therapy at 12 months, proportion monitoring BP at home, adherence to different components of TLC and optimal referral.
- Key Implementation Metrics using the Reach Effectiveness-Adoption Implementation and Maintenance (RE-AIM) framework (Implementation research metric/ framework)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation (STEMI) Myocardial Infarction of Anterior WallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 1,560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. John's Research Institute
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Denis Xavier, Dr., Principal investigator, St. John's Medical College and research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836661
- Sponsor's protocol ID
- 293/2023
- Acronym
- ENABLE
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in specific publication arising out of the trial, after de-identification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect, Cost, and sustaiNability of a Synergistic, Multipronged, Customized, Low-cost Intervention Package to Reduce cArdiovascular Burden Across India: a cLustEr RCT
- ClinicalTrials.gov ID
- NCT06836661
- Acronym / sponsor ID
- ENABLE / 293/2023
- Keywords
- CVD, Low cost intervention, task sharing, fixed dose combination pills
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,560 participants (estimated)
- Lead sponsor
- St. John's Research InstituteUniversity, hospital or other
- 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
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular diseases (CVD) are the leading cause of death worldwide, responsible for approximately 17.9 million deaths each year, which accounts for 31% of all global deaths. The majority of these deaths-about 85%-are due to heart attacks and strokes. In India, CVD has contributed to 28·1% of the total deaths and 14·1% of the total DALYs. There is a remarkably high burden of CVD in India, with an age-standardised death rate of 282 deaths/100,000 (264-293) compared with global levels (233 deaths per 100,000 (229-236). Ischemic heart disease and stroke have been identified as the top two causes of mortality in the country, highlighting the urgent need for effective interventions.
Evidence supports the effectiveness of fixed dose combination treatments and the use of Non-Physician Health Workers (NPHWs) in primary and secondary prevention of CVD. India's healthcare system faces the dual challenge of rising CVD mortality and a lack of integrated preventive and management strategies for CVD at both the primary and secondary care levels. NPHWs play a major role in reducing CVD risk factors.
Despite the growing burden of CVD, there is a notable lack of evidence in India that evaluate comprehensive CVD management strategies across multiple levels, particularly focusing on hard clinical endpoints such as mortality, myocardial infarction (MI), stroke, and cardiovascular hospitalisations. To fill these gaps, we need a robust implementation trial that evaluates the effectiveness of multiple proven interventions in diverse settings on hard clinical endpoints. Such a trial, likely the first of its kind, would provide key evidence to guide policy decisions to improve CVD management strategies in India.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention arm - FDC and TLC and medication adherance | Experimental | Behavioral: FDC and TLC and medication adheranceNPHW enabled education and counseliing along with prescribing combination therapies and TLC and availability of low cost rational FDC at hospital pharmacy |
| Control arm - Patients will Enhanced Usual Care (EUC) | Experimental | Behavioral: Patients will Enhanced Usual Care (EUC)Enhanced Usual Care (EUC) with periodic follow ups. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- We will exclude patients with any ONE of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDC and TLC and medication adheranceLevel 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 | Behavioural | Intervention arm - FDC and TLC and medication adherance |
| Patients will Enhanced Usual Care (EUC)Patients will Enhanced Usual Care (EUC) with periodic follow ups | Behavioural | Control arm - Patients will Enhanced Usual Care (EUC) |
Primary outcome
Composite of death, myocardial infarction, stroke and CVD-related hospitalisations at three years
Time frame: 3 years
1 secondary outcome
The Cost-Effectiveness (incremental cost- effectiveness ratio, ICER) of the IP
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in specific publication arising out of the trial, after de-identification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Denis Xavier, Dr. principal investigator
St. John's Medical College and research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDC and TLC and medication adherance in people with ST Elevation (STEMI) Myocardial Infarction of Anterior Wall and Cardiovascular Diseases, run by St. John's Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denis Xavier, Dr. (49466141 ext. 91-80, denis.xavier@stjohns.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of death, myocardial infarction, stroke and CVD-related hospitalisations at three years (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.