[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620676":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":23,"locations":31,"responsibleParty":45,"collaborators":23,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":23,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":70,"whyStopped":23,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"U. N. Mehta Institute of Cardiology and Research Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Alteplase","ACTIVE_COMPARATOR","Low Dose (25 mg) Ultra-slow (24 hr) Infusion of Alteplase Without Bolus (max 72 hrs)",[13,14],"Drug: Alteplase","Drug: streptokinase",{"label":16,"type":10,"description":17,"interventionNames":18},"Streptokinase","Slow (24hr) Infusion of 25 lac units Streptokinase (2.5 lac 1st hr → 1 lac \u002Fhr for 23 hrs) (max 48 hrs)",[13,14],[20,24],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},"DRUG",[9,16],null,{"type":21,"name":25,"description":17,"armGroupLabels":26,"otherNames":23},"streptokinase",[9,16],[28],{"name":29,"affiliation":5,"role":30},"Sibasis Sahoo, DM","PRINCIPAL_INVESTIGATOR",[32],{"facility":33,"status":23,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":23},"Dr.Sibasis Sahoo","Ahmedabad","Gujarat","380016","India","IN",{"type":40,"coordinates":41},"Point",[42,43],72.58727,23.02579,{"lat":43,"lon":42},{"type":30,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Dr. Sibasis Sahoo","Professor, Department of Cardiology","100620676","to-compare-the-efficacy--safety-of-ultra-slow-24-hr-low-dose-25-mg-infusion-of-alteplase-over-slow-24hr-infusion-of-streptokinase-in-mechanical-prosthetic-valve-thrombosis-100620676",false,"NCT07360717","To Compare the Efficacy & Safety of Ultra-Slow (24 hr) Low Dose (25 mg) Infusion of Alteplase Over Slow (24hr) Infusion of Streptokinase in Mechanical Prosthetic Valve Thrombosis","To Compare the Efficacy & Safety of Ultra-Slow (24 hr) Low Dose (25 mg) Infusion of Alteplase Over Slow (24hr) Infusion of Streptokinase in Mechanical Prosthetic Valve Thrombosis : A Randomized Controlled Trial","PHVT","patients with Written Informed Consent All adult patients of Mechanical PVT, Patient planned for Thrombolysis as first option as per common decision of Treating Cardiologist and CVTS Team.","ALL","18 Years","60 Years",{"count":60,"type":61},100,"ACTUAL","INTERVENTIONAL",[64],"NA","Annual incidence of PVT for mechanical valves is 0.3 - 1.3% patient-yrs. First postoperative year is marked by a 24% incidence of thrombosis. Stable incidence between the second to fourth years (\\~ 15%), and a subsequent decrease afterward. Mortality rates of Re-do Surgery have been reported to be from 6% to 69% (average 12%) Thrombolytic therapy as a First-line strategy is being used with successful outcomes. To Study the Efficacy \\& Safety of Low Dose (25 mg) Ultra-slow (24 hr) Infusion of Alteplase Without Bolus (max 72 hrs) over Slow (24hr) Infusion of 25 lac units Streptokinase (2.5 lac 1st hr → 1 lac \u002Fhr for 23 hrs) (max 48 hrs) in Mechanical PVT.\n\nObjectives :\n\nPrimary :\n\nTo compare the success rate of USLD Alteplase thrombolysis over Streptokinase To compare the complication rates (minor + non-fatal major + fatal) in both the study groups\n\nSecondary:\n\nTo study the clinical profile of patients presenting with Mechanical PVT. Single Centre Open Label Randomized Controlled Trial Sample Size : 100 (50 each) Follow up : Till Hospital Discharge Pt randomized as per Computer Generated Random Number Started on Inj Heparin Infusion till initiation of Thrombolysis. Repeat 2D Echo at 6 Hrs, 12 Hrs and 24 Hrs Interval \\& as required. Repeat Fluoroscopy \u002F TEE if Echocardiographic evidence of improvement in gradient or moving leaflets \u002F at 24 hrs interval.\n\nExtended Thrombolysis with STK (max 48 hrs) \u002F Alteplase (Max 72 hrs) Restarting of Heparin Infusion In between time lags for next continuation of Thrombolysis \u002F Surgery\u002F attaining Therapeutic INR Post-thrombolysis Follow up till Discharge for Outcome",[67],"Thrombolysed",[69],"Pulmonary heart valve thrombosis","COMPLETED","2026-01-22",{"date":73,"type":61},"2026-01-26",{"date":75,"type":61},"2024-11-01",{"date":77,"type":61},"2025-12-31",{"name":5,"class":6},1]