[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647805":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":48,"responsibleParty":61,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"National Institute of Cardiovascular Diseases, Pakistan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ivabradine Plus Standard Care","EXPERIMENTAL","Participants will receive standard treatment for STEMI complicated by cardiogenic shock, including revascularization, guideline-directed medical therapy as clinically appropriate, standardized vasopressor and inotropic support, and mechanical circulatory support when indicated. Participants will receive ivabradine 5 mg orally twice daily for up to 3 days, with a maximum of six doses. Study treatment will be discontinued if the heart rate decreases to \\\u003C72 bpm or a beta-blocker is initiated.",[13],"Drug: Ivabradine 5mg Tab",{"label":15,"type":16,"description":17,"interventionNames":18},"Matching Placebo Plus Standard Care","PLACEBO_COMPARATOR","Participants will receive the same standard treatment for STEMI complicated by cardiogenic shock, including revascularization, guideline-directed medical therapy as clinically appropriate, standardized vasopressor and inotropic support, and mechanical circulatory support when indicated. Participants will receive a matching placebo tablet orally twice daily for up to 3 days, with a maximum of six doses. Study treatment will be discontinued if the heart rate decreases to \\\u003C72 bpm or a beta-blocker is initiated.",[19],"Drug: Placebo Oral Tablet",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ivabradine 5mg Tab","Ivabradine 5mg oral BID for 3 days (6 tablets)",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Oral Tablet","Placebo tablets, with same color and texture, for 3 days in BID doses",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Asim Ali, MBBS","National Institute of Cardiovascular Diseases","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":34,"role":38},"Abdul Hakeem, MD FACC, FSCAI, FASE","STUDY_CHAIR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Umair Saleem, MBBS","CONTACT","+923363937264","umairsaleem1002@gmail.com",{"name":33,"role":42,"phone":46,"phoneExt":26,"email":47},"+92 301 3717252","dr.aasemali@gmail.com",[49],{"facility":50,"status":51,"city":52,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":26},"National institute of cardiovascular diseases","RECRUITING","Karachi","Pakistan","PK",{"type":56,"coordinates":57},"Point",[58,59],67.0104,24.8608,{"lat":59,"lon":58},{"type":35,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Dr Asim Ali","Senior Registrar","100647805","phase-3-ivabradine-in-the-acute-management-of-cardiogenic-shock-100647805",false,"NCT07714746","Ivabradine in the Acute Management of Cardiogenic Shock","Ivabradine in the Acute Management of Cardiogenic Shock - IVASHOCK-a Double-blind Randomized Controlled Trial","IVASHOCK","Inclusion Criteria:\n\n* Patients aged 18-75 years diagnosed with STEMI complicated by cardiogenic shock (CS) as defined by SCAI shock classification \\> C:\n\nSigns of Hypoperfusion including:\n\n1. SBP \\\u003C90 OR MAP \\\u003C60 OR \\>30 mmHg drop from baseline AND drugs\u002Fdevice used to maintain BP above these targets\n2. Cold, clammy extremities\n3. Urine output \\\u003C30 mL\u002Fh\n4. pulmonary congestion (either crackles, congestion in chest X-ray or B-lines in lung US)\n5. Mixed venous oxygen saturation ≤ 65%\n\n   * Severe Left ventricular (LV) dysfunction or right ventricular (RV) infarction\n   * Heart rate (HR) ≥ 100 bpm (Sinus Rhythm) in whom beta-blocker therapy cannot be initiated, including: On inotropic or vasopressor support, Requiring an intra-aortic balloon pump (IABP), With Killip class III or IV, Requiring BiPAP or mechanical ventilation\n\nExclusion Criteria:\n\n* Age \\> 75 years\n* CPR \\> 12 mints\n* Atrial fibrillation\n* Complete Heart Block\n* Heart rate of \\\u003C 100 bpm\n* End stage Renal Disease\n* Extensive comorbidities; Prior CVA, Malignancy, Pregnancy or Ongoing Participation in Other Trials","ALL","18 Years","75 Years",{"count":76,"type":77},200,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","Brief Summary:\n\nThe IVASHOCK trial investigates whether ivabradine can achieve at least one-class improvement in SCAI cardiogenic shock classification compared to placebo, and evaluates its safety profile in patients with cardiogenic shock (CS).\n\nPrimary Objectives:\n\n1. To determine whether ivabradine improves SCAI shock classification by at least one class from baseline within 72 hours compared to placebo\n2. To assess whether ivabradine facilitates earlier weaning from vasoactive and inotropic support compared to placebo\n\nSafety Endpoints:\n\nAdverse events monitored include: sinus node dysfunction, new-onset atrial fibrillation or atrial flutter, atrioventricular block, drug-related hypotension, and ventricular arrhythmia.\n\nParticipant Schedule:\n\nParticipants will receive ivabradine or placebo orally every 12 hours for 3 days.\n\nHemodynamic and metabolic assessments will include:\n\nArterial pH, central venous oxygen saturation (ScvO2), and serum lactate - every 6 hours on Day 1, then every 8 hours on Days 2 and 3 Heart rate, mean arterial pressure (MAP), vasoactive\u002Finotropic support dose, and urine output - measured on the same timeline",[83],"Cardiogenic Shock Post Myocardial Infarction",[85,86,87,88,89,90],"ivabradine","cardiogenic shock","SCAI Shock Stage Classification","Heart Rate Reduction","Randomized clinical trial","Shock Severity Improvement","2026-07-14",{"date":93,"type":94},"2026-07-20","ACTUAL",{"date":96,"type":94},"2026-04-20",{"date":98,"type":77},"2027-05-31",{"name":5,"class":6},1]