[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582289":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":40,"collaborators":25,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":25,"maxAge":25,"enrollmentInfo":51,"targetDuration":25,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":62,"whyStopped":25,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":25},{"fullName":5,"class":6},"First Affiliated Hospital Xi'an Jiaotong University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bivalirudin","EXPERIMENTAL","bivalirudin with a prolonged infusion",[13],"Drug: Bivalirudin",{"label":15,"type":16,"description":17,"interventionNames":18},"Heparin","ACTIVE_COMPARATOR","Heparin alone during PCI",[19],"Drug: Unfractionated heparin",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","For rescued PCI, do not recommend to include patient who's ACT is more than 350s.\n\nIf fibrinolysis is successful, monitor ACT and wait till it's lower than 350s before randomization.\n\nMonitor ACT before angiography, (1) if ACT\\\u003C180, bivalirudin 0.75 mg\u002Fkg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg\u002Fkg\u002Fh until 2-4 hours after PCI; (2) if 180s\\\u003CACT\\\u003C225s, bivalirudin 0.5mg\u002Fkg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg\u002Fkg\u002Fh until 2-4 hours after PCI; (3) if ACT\\>225s, bivalirudin intravenous infusion of 1.75 mg\u002Fkg\u002Fh until 2-4 hours after PCI. (4) ACT be monitored 5 minutes after the first administration, and if ACT is \\\u003C225 s, intravenous injection of 0.3 mg\u002Fkg of bivalirudin should be administered, and the ACT re-checked to ensure it is \\>225 seconds.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Unfractionated heparin","(1)If ACT\\\u003C180s, administer an intravenous bolus of unfractionated heparin at 70 U\u002Fkg before coronary angiography, with a maximum total dose of 6000U. (2)If 180\\\u003CACT\\\u003C225s, administer an intravenous bolus of unfractionated heparin at 60 U\u002Fkg before coronary angiography, with a maximum total dose of 4000U. (3)If ACT\\>225s, proceed directly with PCI and maintain 225s\\\u003CACT\\\u003C350s.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Tao Chen, MD","CONTACT","(86)13891995622","chentao0331@xjtu.edu.cn",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Chenbo Xu, MD","(86)13468763406","xuchenbox@qq.com",{"type":41,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100582289","bivalirudin-with-prolonged-infusion-during-pci-versus-heparin-after-fibrinolytic-therapy-100582289",false,"NCT06861374","Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy","Bivalirudin Plus High-Dose Infusion Versus Heparin Monotherapy in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention After Fibrinolysis: a Randomized Trial","BRIGHT-FIT","Inclusion Criteria:\n\n* Any age\n* STEMI patients received fibrinolysis therapy within 12h of symptom onset and are planned to undergo PCI within 24h of symptom onset.\n* Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor)\n* Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin);\n* The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent.\n\nExclusion Criteria:\n\n* Not suitable for PCI;\n* Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.);\n* Cardiogenic shock(Killip IV)\n* Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor\n* Patients who underwent PCI in past 30 days\n* Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug\u002Finstrument study or undergoing another drug\u002Finstrument study, pregnancy).","ALL",{"count":52,"type":53},2400,"ESTIMATED","INTERVENTIONAL",[56],"NA","This multicenter, randomized controlled trial in China aims to enroll 2,400 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 24 hours post-fibrinolysis. Participants will be randomly assigned in a 1:1 ratio to receive either bivalirudin or heparin, with follow-up at 30 days and 1 year. The primary endpoint is a composite of all-cause mortality and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 30 days.",[59],"ST-segment Elevation Myocardial Infarction (STEMI)",[61],"STEMI, PCI, fibrinolysis, bivalirudin, heparin, bleeding, mortality","NOT_YET_RECRUITING","2025-03-03",{"date":65,"type":66},"2025-03-06","ACTUAL",{"date":68,"type":53},"2025-05",{"date":70,"type":53},"2029-03",{"name":5,"class":6}]