[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575205":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Henan Institute of Cardiovascular Epidemiology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intracoronary rhTNK-tPA","EXPERIMENTAL",null,[13],"Drug: rhTNK-tPA, 4-8 mg",{"label":15,"type":16,"description":11,"interventionNames":17},"Intracoronary Tirofiban","ACTIVE_COMPARATOR",[18],"Drug: Tirofiban",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","rhTNK-tPA, 4-8 mg","Intracoronary influsion of rhTNK-tPA (4 mg). After 10 minutes of administration, 4 mg may be given again if the thrombus burden is not significantly reduced.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Tirofiban","Intracoronary influsion of Tirofiban (10 µg\u002Fkg) , and then administered intravenously at 0.075-0.15 µg\u002Fkg.min for 36 h or longer",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"You Zhang","CONTACT","+86 37158681037","13598019682@126.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Fuwai Central China Cardiovascular Hospital","RECRUITING","Zhengzhou","Henan","China","CN",{"type":44,"coordinates":45},"Point",[46,47],113.64861,34.75778,{"lat":47,"lon":46},[50],{"name":31,"role":32,"phone":51,"phoneExt":11,"email":11},"+8637158681037",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Chuanyu Gao","Director","100575205","phase-4-intracoronary-rhtnk-tpa-versus-tirofiban-in-patients-with-stemi-and-high-thrombus-burden-100575205",false,"NCT06769256","Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden","Effects of Intracoronary Recombinant Human TNK Tissue-type Plasminogen Activator Versus Tirofiban on Myocardial Perfusion and Clinical Prognosis in Patients With ST-segment Elevation Myocardial Infarction and High Thrombus Burden: a Multicenter, Randomized, Controlled, Single-blind, Non-inferior Study","H2-THROMBUS","Inclusion Criteria:\n\n* Age 18-75 years old;\n* STEMI within 12 hours of onset;\n* TIMI flow grade 0-2 or TIMI thrombus grade ≥4 after thrombus aspiration or balloon dilation\n* Radial artery access\n\nExclusion Criteria:\n\n* A functional coronary collateral supply (Rentrop grade≥2) to the infarctrelated artery\n* Known or suspected old myocardial infarction of target vessels\n* Rescue PCI\n* Cardiogenic shock\n* Contraindications to Tirofiban or rhTNK-tPA\n* Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate \\\u003C30ml\u002Fmin\u002F1.73m2, or on dialysis)\n* Prolonged (\\> 10 minutes) cardiopulmonary resuscitation\n* Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall)\n* Severe chronic obstructive pulmonary disease or respiratory failure\n* Severe infection\n* Neurological disorders\n* Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year\n* Pregnant or lactating women","ALL","18 Years","75 Years",{"count":68,"type":69},300,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","The goal of this clinical trial is to compare the efficacy and safety of intracoronary rhTNK-tPA or Tirofiban in patients with ST-segment elevation myocardial infarction and high thrombus burden. The main questions it aims to answer are:\n\n* Is the efficacy of intracoronary rhTNK-tPA non-inferior to intracoronary Tirofiban for the treatment of ST-segment elevation myocardial infarction in patients wiht high thrombus burden?\n* Does intracoronary rhTNK-tPA increase the incidence of bleeding events?\n\nThis multicenter RCT study plans to enroll 300 patients, who are randomly divided into two groups: intracoronary rhTNK-tPA or Tirofiban by 1:1. The primary efficacy endpoint was post-PCI corrected TIMI frame count (CTFC). Major adverse events (death, recurrent myocardial infarction, ischemic stroke, or hospitalization for heart failure) were observed at 1 year follow-up.",[75],"ST-segment Elevation Myocardial Infarction (STEMI)","2026-05-19",{"date":78,"type":79},"2026-05-22","ACTUAL",{"date":81,"type":79},"2025-01-01",{"date":83,"type":69},"2027-12-30",{"name":5,"class":6},1]