[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514902":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":42,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":42,"enrollmentInfo":74,"targetDuration":42,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"bivalirudin group","EXPERIMENTAL","participants using bivalirudin during PCI",[13],"Drug: Bivalirudin",{"label":15,"type":16,"description":17,"interventionNames":18},"standard heparin group","ACTIVE_COMPARATOR","participants using standard heparin during PCI",[19],"Drug: standard heparin",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bivalirudin","Participants in the bivalirudin group received a one-time intravenous injection of 0.75 mg\u002Fkg during PCI, and then received a continuous intravenous infusion of 1.75 mg\u002Fkg\u002Fh for 4 hours according to the participants' condition after PCI.",[9],[27],"bivalirudin anticoagulation",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"standard heparin","Participants in the standard heparin group received a one-time intravenous injection of 50 U\u002Fkg of standard heparin during PCI.",[15],[33],"standard heparin anticoagulation",[35],{"name":36,"affiliation":5,"role":37},"Bo Zheng, Prof","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","13426046980",null,"zhengbopatrick@163.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Peking university first hospital","RECRUITING","Beijing","Beijing Municipality","10034","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.39723,39.9075,{"lat":57,"lon":56},[60],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},{"type":37,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"ZHENG Bo","associate professor","100514902","phase-4-a-study-on-the-impact-of-bivalirudin-usage-during-pci-for-high-risk-plaques-on-post-pci-coronary-microcirculation-100514902",false,"NCT05984537","A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.","A Study on the Impact of Bivalirudin Usage During Percutaneous Coronary Intervention for High-risk Plaques in the Coronary Artery on Post Percutaneous Coronary Intervention Coronary Microcirculation.","PCI","Inclusion Criteria:\n\n1. aged 18 years or older;\n2. diagnosed with non-ST-segment elevation myocardial infarction or unstable angina pectoris;\n3. scheduled to undergo elective coronary angiography and intervention;\n4. coronary computed tomography angiography showing high-risk plaque features within 3 months prior to the procedure;\n5. voluntary participation in the study and signed informed consent.\n\nExclusion Criteria:\n\n1. prior PCI of the target vessel within 3 months;\n2. cardiogenic shock, active bleeding, bleeding disorders, irreversible coagulation dysfunction, severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2), and dependence on dialysis;\n3. life expectancy less than 1 year;\n4. chronic total occlusion of the target vessel;\n5. poor opacification of the target vessel, severe vessel overlap or distortion, and inability to completely expose the lesion site;\n6. allergy to contrast agents, verapamil, or its excipients;\n7. severe uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg);\n8. subacute bacterial endocarditis.","ALL","18 Years",{"count":75,"type":76},70,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","In this study, investigators enrolled patients with coronary heart disease who were scheduled to undergo percutaneous coronary intervention (PCI) and had high-risk plaques according to computed tomography angiography (CTA). During the PCI procedure, patients will be randomly assigned to receive either bivalirudin or standard heparin anticoagulation therapy. Investigators will compare the post-PCI coronary angiography-derived index of microcirculatory resistance (CaIMR), thrombolysis in myocardial infarction (TIMI) blood flow grade, CTFC (corrected TIMI frame count), TIMI myocardial perfusion grading(TMPG), levels of troponin, and major adverse cardiac events (MACE) during a follow-up period of 6 months between the two groups. Investigators aim to explore the potential benefits of bivalirudin perioperative anticoagulation therapy in improving coronary microvascular dysfunction (CMD) after PCI for high-risk plaques in coronary artery lesions.",[82],"Coronary Microvascular Dysfunction",[84,85,86,87,88],"coronary microvascular dysfunction","computed tomography angiography","percutaneous coronary intervention","bivalirudin","heparin","2025-08-07",{"date":91,"type":92},"2025-08-12","ACTUAL",{"date":94,"type":92},"2023-07-01",{"date":96,"type":76},"2026-01-04",{"name":5,"class":6},1]