[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650523":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":49,"locations":59,"responsibleParty":80,"collaborators":83,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":35,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":118,"whyStopped":35,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Rehman Medical Institute - RMI","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-reperfusion Empagliflozin","EXPERIMENTAL","Participants receive a single empagliflozin 25 mg loading dose immediately after randomization, before cath-lab transfer, with no delay to primary PCI, followed by a matched placebo dose within 2 hours after PCI. Empagliflozin 10 mg once daily is then continued for 90 days, in addition to guideline-directed standard care.",[13,14],"Drug: empagliflozin","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Post-reperfusion Empagliflozin","Participants receive a matched placebo dose before primary PCI, followed by a single empagliflozin 25 mg loading dose within 2 hours after successful PCI. Empagliflozin 10 mg once daily is then continued for 90 days, in addition to guideline-directed standard care.",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Participants receive matched placebo before primary PCI and again within 2 hours after PCI, followed by matched placebo once daily for 90 days, in addition to guideline-directed standard care.",[14],[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","empagliflozin","Empagliflozin is an oral sodium-glucose cotransporter-2 (SGLT2) inhibitor administered in addition to guideline-directed medical therapy for acute ST-segment elevation myocardial infarction (STEMI). Participants randomized to the experimental groups receive empagliflozin according to the study protocol. In one experimental arm, empagliflozin is administered before primary percutaneous coronary intervention (PCI) (pre-reperfusion), whereas in the second experimental arm, it is administered immediately after successful reperfusion by primary PCI (post-reperfusion). All subsequent dosing, follow-up, and safety monitoring are conducted according to the protocol.",[16,9],[31],"Jardiance",{"type":26,"name":20,"description":33,"armGroupLabels":34,"otherNames":35},"Participants randomized to the control arm receive matching placebo tablets that are identical in appearance, packaging, and administration schedule to empagliflozin. Placebo is administered in addition to guideline-directed medical therapy to maintain blinding throughout the study. The placebo regimen follows the same schedule as the active intervention without containing the active pharmaceutical ingredient.",[20,16,9],null,[37,41,45],{"name":38,"affiliation":39,"role":40},"Miqdad A Khan, MD, FACC, FISCI, FSCAI, FACP","Rehman Medical Institute","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":43,"role":44},"Herbert D Aronow, MD, MPH, MSCAI, FACC, MSVM","Michigan State University College of Human Medicine","STUDY_CHAIR",{"name":46,"affiliation":47,"role":48},"Ashraf S Niazi, MBBS, FRCP","Northampton General Hospital, UK","STUDY_DIRECTOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":35,"email":54},"Syed M Rayyan, MBBS","CONTACT","+923369949269","drsmuhammadrayyan@gmail.com",{"name":56,"role":52,"phone":57,"phoneExt":35,"email":58},"Hammad Saif, MBBS","+923349903737","hammadsaif7690@gmail.com",[60],{"facility":39,"status":35,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Peshawar","Khyber Pakhtun Khwa","25000","Pakistan","PK",{"type":67,"coordinates":68},"Point",[69,70],71.57849,34.008,{"lat":70,"lon":69},[73,76,78],{"name":74,"role":52,"phone":75,"phoneExt":35,"email":54},"Syed Muhammad Rayyan, MBBS","+92 3369949269",{"name":56,"role":52,"phone":77,"phoneExt":35,"email":58},"+92 334 9903737",{"name":79,"role":40,"phone":35,"phoneExt":35,"email":35},"Miqdad Ali Khan, MD FACC FSCAI FACP FISCI",{"type":40,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Miqdad Ali Khan","HOD & Consultant Cardiologist",[84],{"name":85,"class":6},"Michigan State University","100650523","phase-2-timing-of-empagliflozin-in-primary-pci-pre-reperfusion-versus-post-reperfusion-versus-placebo-in-south-asian-stemi-patients-100650523",false,"NCT07749014","Timing of Empagliflozin in Primary PCI: Pre-Reperfusion Versus Post-Reperfusion Versus Placebo in South Asian STEMI Patients","TEMPO-STEMI","Inclusion Criteria:\n\n* Age 18-75 years at presentation.\n* South Asian ethnicity (Pakistani, Indian, Bangladeshi, Sri Lankan, or Nepali origin).\n* First STEMI: ST-elevation ≥1 mm in ≥2 contiguous limb leads, or ≥2 mm in ≥2 contiguous precordial leads, or new LBBB with consistent presentation.\n* Symptom onset to hospital arrival ≤12 hours.\n* Scheduled for primary PCI with intent to perform balloon inflation and stenting.\n* eGFR ≥45 mL\u002Fmin\u002F1.73m² (CKD-EPI) from point-of-care creatinine at presentation.\n* Able to take oral medication (or crushed tablet with water), swallowing ability confirmed by treating nurse.\n* Written informed consent from patient or legally authorised representative\n\nExclusion Criteria:\n\n* Cardiogenic shock at presentation (Killip IV: SBP \\\u003C90 mmHg despite volume, requiring vasopressors, IABP, or mechanical circulatory support).\n* Type 1 diabetes mellitus.\n* SGLT2 inhibitor use within 3 months of presentation.\n* Active urinary tract infection or genital mycotic infection.\n* eGFR \\\u003C45 mL\u002Fmin\u002F1.73m² at presentation.\n* Severe hepatic impairment (Child-Pugh Class C).\n* Known hypersensitivity to empagliflozin or any SGLT2 inhibitor.\n* History of diabetic ketoacidosis (euglycaemic or classical) at any time.\n* Pregnancy, breastfeeding, or refusal of contraception (women of childbearing potential).\n* Prior myocardial infarction or prior coronary revascularisation.\n* Left main culprit artery as the infarct-related vessel.\n* Rescue PCI after fibrinolysis in the current presentation.\n* Severe multivessel disease with anticipated need for urgent CABG within 48 hours.\n* Cardiac arrest with coma (GCS \\\u003C8) at presentation consent not obtainable and metabolic state unpredictable.\n* Significant metabolic abnormality precluding oral drug: severe vomiting, nil-by-mouth status, or frank dehydration with SBP \\\u003C100 mmHg on arrival.\n* Concurrent participation in another interventional clinical trial.\n* Life expectancy \\\u003C6 months from a non-cardiac cause.\n* Expected inability to attend the 90-day follow-up visit.","ALL","18 Years","75 Years",{"count":97,"type":98},480,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","The goal of this clinical trial is to learn if giving the drug empagliflozin before versus after a heart procedure called primary PCI (percutaneous coronary intervention) affects how much heart muscle is damaged during a heart attack. Primary PCI is a procedure that opens blocked heart arteries using a small balloon and stent. While this procedure saves lives, it can also cause extra injury to the heart muscle when blood flow returns. Researchers want to know if empagliflozin given before the procedure can protect the heart better than giving it after the procedure.\n\nThe main questions this trial aims to answer are:\n\nDoes giving empagliflozin before the PCI procedure reduce heart muscle injury more than a placebo (a look-alike pill with no active drug)?\n\nDoes giving empagliflozin before PCI protect the heart better than giving it after PCI?\n\nDoes empagliflozin given after PCI reduce heart muscle injury compared with a placebo?\n\nResearchers will compare three groups of participants to see if the timing of empagliflozin matters:\n\nGroup A receives empagliflozin before the PCI procedure\n\nGroup B receives empagliflozin after the PCI procedure\n\nGroup C receives a placebo at both times\n\nAll three groups will continue taking their assigned study pills for 90 days.\n\nParticipants in this study are adults aged 18 to 75 from South Asian backgrounds (Pakistani, Indian, Bangladeshi, Sri Lankan, or Nepali) who are having their first heart attack and are scheduled for the PCI procedure within 12 hours of their symptoms starting.\n\nParticipants will:\n\nTake a single loading dose of the study pill or placebo right before the PCI procedure\n\nTake a single loading dose of the study pill or placebo within 2 hours after the PCI procedure\n\nContinue taking the study pill or placebo once daily for 90 days\n\nHave blood samples taken 6 times over 48 hours to measure heart muscle injury\n\nHave heart function tests at Day 3, Day 30, and Day 90 (echocardiograms, which are ultrasound pictures of the heart)\n\nHave a special heart scan (CMR) between Day 3 and Day 5 for some participants to get detailed pictures of the heart muscle\n\nComplete 90 days of follow-up with clinic visits and tests\n\nResearchers will measure heart muscle injury using a blood test called high-sensitivity troponin. This test measures a protein that is released when heart muscle is damaged. The total amount of this protein released over 48 hours will tell researchers how much heart muscle was injured.",[104,105,106],"ST-elevation Myocardial Infarction (STEMI)","Acute Myocardial Infarction (AMI)","Coronary Artery Disease",[108,109,110,111,112,113,114,115,116,117],"Empagliflozin","SGLT2 Inhibitor","ST-elevation myocardial infarction","Primary Percutaneous Coronary Intervention","Primary PCI","Ischemia-Reperfusion Injury","Myocardial Infarction","Troponin I","Cardioprotection","South Asian Population","NOT_YET_RECRUITING","2026-07-31",{"date":121,"type":122},"2026-08-06","ACTUAL",{"date":124,"type":98},"2026-09-01",{"date":126,"type":98},"2027-09-30",{"name":5,"class":6},1]