[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580389":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":62,"collaborators":64,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":103,"whyStopped":25,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"St. John's Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13],"Behavioral: FDC and TLC and medication adherance",{"label":15,"type":10,"description":16,"interventionNames":17},"Control arm - Patients will Enhanced Usual Care (EUC)","Enhanced Usual Care (EUC) with periodic follow ups.",[18],"Behavioral: Patients will Enhanced Usual Care (EUC)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","FDC and TLC and medication adherance","Level 1: Patient 1. Rational FDCs 2. NPHWs and PMs mediated therapeutic lifestyle changes 3. Texts\u002F 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",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Patients will Enhanced Usual Care (EUC)","Patients will Enhanced Usual Care (EUC) with periodic follow ups",[15],[31],{"name":32,"affiliation":33,"role":34},"Denis Xavier, Dr.","St. John's Medical College and research Institute","PRINCIPAL_INVESTIGATOR",[36,41],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","49466141","91-80","denis.xavier@stjohns.in",{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},"Deepa S, Dr.","49467081","deepa.sn@sjri.res.in",[46],{"facility":47,"status":25,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Division of Clinical Research and training St. John's Research Institute Koramangala , - , India","Bangalore","Karnataka","560034","India","IN",{"type":54,"coordinates":55},"Point",[56,57],77.59369,12.97194,{"lat":57,"lon":56},[60,61],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[65,68,70,73,75],{"name":66,"class":67},"Assam Medical College, Dibrugarh, India","UNKNOWN",{"name":69,"class":67},"SRM Medical College Hospital & Research Centre",{"name":71,"class":72},"Jawaharlal Institute of Postgraduate Medical Education & Research","OTHER_GOV",{"name":74,"class":72},"Indian Council of Medical Research",{"name":76,"class":6},"All India Institute of Medical Sciences, Bhopal","100580389","impact-cost-and-sustainability-of-a-customized-low-cost-intervention-to-reduce-cardiovascular-disease-burden-in-india-a-cluster-randomized-trial-100580389",false,"NCT06836661","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","ENABLE","Inclusion Criteria:\n\n\\- 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, \\\u003Cbr\u002F\\> 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).\n\nc. 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.\n\nExclusion Criteria:\n\n* We will exclude patients with any ONE of the following:\n\n  1. Severe cognitive impairment of any aetiology and have no reliable caregivers.\n  2. Medical conditions with a survival prognosis of less than 12 months.\n  3. Unable to follow-up for the study period","ALL","40 Years","99 Years",{"count":89,"type":90},1560,"ESTIMATED","INTERVENTIONAL",[93],"NA","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.",[96,97],"ST Elevation (STEMI) Myocardial Infarction of Anterior Wall","Cardiovascular Diseases",[99,100,101,102],"CVD","Low cost intervention","task sharing","fixed dose combination pills","NOT_YET_RECRUITING","2025-05-14",{"date":106,"type":107},"2025-05-18","ACTUAL",{"date":109,"type":90},"2025-06-01",{"date":111,"type":90},"2029-06-30",{"name":5,"class":6},1]