[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610566":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":56,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"National Institute of Cardiovascular Diseases, Pakistan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DCB arm (Prevail Drug Coated Balloon)","EXPERIMENTAL","Patients assigned to drug coated balloon",[13],"Device: Drug coated balloon (Prevail; Medtronic Inc.)",{"label":15,"type":16,"description":17,"interventionNames":18},"DES arm (Limus drug eluting stent)","ACTIVE_COMPARATOR","Patients receiving standard of care Drug eluting stent",[19],"Device: Drug eluting stent",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Drug coated balloon (Prevail; Medtronic Inc.)","Drug coated balloon (Prevail DCB, Medtronic Inc.)",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Drug eluting stent","standard of care",[15],[32],{"name":33,"affiliation":34,"role":35},"Abdul Hakeem, MD","NICVD","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+923355554342","ahakeem@gmail.com",[42],{"facility":43,"status":44,"city":45,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"National Institute of Cardiovascular Diseases","RECRUITING","Karachi","Pakistan","PK",{"type":49,"coordinates":50},"Point",[51,52],67.0104,24.8608,{"lat":52,"lon":51},[55],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":35,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Professor Abdul Hakeem","Professor and Program Director, Interventional Cardiology, Director Cardiac Catheterization Labs","100610566","phase-3-dcb-vs-des-in-young-stemi-patients-the-dcb-stemi-trial-100610566",false,"NCT07229248","DCB vs. DES in Young STEMI Patients: The DCB-STEMI Trial","Drug Coated Balloon vs. Drug Eluting Stent in Young Patients With STEMI: The DCB-STEMI Randomized Trial","DCB-STEMI","Inclusion Criteria:\n\n* Either gender\n* Patient of age between 18 to 50 years\n* Patients with STEMI ( as first presentation of CAD) undergoing Primary PCI\n* Total ischemic Time less than 8 hrs.\n* Low syntax score\n* Stable (Killip I-II)\n\nExclusion Criteria:\n\n* Patients with ESRD\n* Severe 3 VD; Intermediate of High syntax score\n* Lesion type\\>B","ALL","18 Years","49 Years",{"count":71,"type":72},496,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","Background: ST Elevation Myocardial Infarction (STEMI) in young adults (\\\u003C50 yrs) carries high Percutaneous coronary intervention (PCI) risks. While drug-eluting stents (DES) reduce restenosis versus angioplasty, they increase risks of in-stent restenosis, thrombosis, prolonged dual antiplatelet therapy (DAPT), and endothelial dysfunction. Drug-coated balloons (DCB) provide a \"leave nothing behind\" strategy, potentially mitigating these issues. Evidence, including a JACC CVI report, suggests DCB outcomes comparable to DES in STEMI. South Asia faces a heavy burden. The national Institute of Cardiovascular diseases (NICVD), Karachi performed 17,761 primary PCIs in 2022, with 45% in patients \\\u003C50 yrs.\n\nStudy Design: This single-center Randomized Controlled Trial (RCT) compares paclitaxel-coated DCB (3.0 µg\u002Fmm², 30s inflation) vs. Drug eluting stents (DES) in young STEMI patients (\\\u003C50 yrs) undergoing primary PCI. The primary endpoint is 1-year vessel oriented cardiac events (VOCE)= Cardiovascular \u002Fall-cause death, target vessel MI, or Target lesion revascularization (TLR). Secondary endpoints include vessel-oriented CV events, bleeding, TIMI III flow, residual stenosis, abrupt closure, and bailout stenting. An intravascular ultrasound (IVUS) substudy (100 DCB pts) will evaluate remodeling and late lumen loss (LLL) at 6 months.\n\nMethods: 496 patients (248\u002Farm) will be randomized 1:1, powered for non-inferiority (margin 4.5%) assuming VOCE 8.5% (DES) vs. 6.25% (DCB), 80% power, and 5% dropout. Inclusion: age 18-50, STEMI. Exclusion: End stage renal disease (ESRD), severe multivessel disease, complex lesions, or high thrombus burden. All will receive ticagrelor 90 mg BID for 1 month. A pilot of 50 pts will first assess safety (abrupt closure, lesion prep).\n\nAnalysis: Intention-to-treat (ITT) will be primary; modified ITT for secondary endpoints. Statistics include chi-square\u002FFisher for categorical, t-test\u002FWilcoxon for continuous, and Kaplan-Meier\u002FCox for survival. Oversight by data safety monitoring board (DSMB) and Events adjudication Committee (EAC).\n\nSignificance: This trial leverages NICVD's high PCI volume to test DCB as an alternative to DES in young STEMI patients. By avoiding permanent implants, DCB may reduce long-term complications and DAPT needs. The IVUS substudy and pilot phase strengthen rigor. If non-inferiority is proven, DCB could reshape STEMI management in South Asia and similar high-burden regions.",[78],"STEMI (ST Elevation MI)",[80,81,82,83,84],"Drug coated balloon","STEMI","RCT","DES","MACE","2025-11-13",{"date":87,"type":88},"2025-11-14","ACTUAL",{"date":90,"type":72},"2025-11-05",{"date":92,"type":72},"2027-12-26",{"name":5,"class":6},1]