[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615291":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":31,"collaborators":33,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":18,"enrollmentInfo":60,"targetDuration":18,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":73,"whyStopped":18,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":18},{"fullName":5,"class":6},"Second Affiliated Hospital of Nanchang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Intensive lipid-lowering within 24 hours during the perioperative period of AMI (standard treatment + PCSK9 inhibitors)；Recaticimab 450 mg once every 12 weeks",[13],"Drug: Recaticimab",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Standard treatment (antiplatelet drugs, 20mg atorvastatin \u002F 10mg rosuvastatin ± cholesterol absorption inhibitors)",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Recaticimab","Recaticimab 450 mg once every 12 weeks. Group 1 (G1, experimental group): Intensive lipid-lowering therapy within 24 hours during the perioperative period of AMI (standard treatment + PCSK9 inhibitors), treatment for 6 months; Group 2 (G2, control group): standard treatment (antiplatelet drugs, 20 mg atorvastatin\u002F10 mg rosuvastatin ± cholesterol absorption inhibitors). After 6 months, both groups continued with guideline-recommended conventional treatment.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Long Jiang, Ph.D.","CONTACT","+86-13767026990","skyiadx@hotmail.com",{"type":32,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[34,36,38,40,42,44,46,48],{"name":35,"class":6},"First Affiliated Hospital of Gannan Medical University",{"name":37,"class":6},"Jiujiang No.1 People's Hospital",{"name":39,"class":6},"First People's Hospital of FuZhou",{"name":41,"class":6},"Yueyang Central Hospital",{"name":43,"class":6},"The First People's Hospital of Changde City",{"name":45,"class":6},"ZhuZhou Central Hospital",{"name":47,"class":6},"Xiangtan Central Hospital",{"name":49,"class":6},"Loudi Central Hospital","100615291","phase-4-intensive-cholesterol-lowering-within-24-hours-of-pci-perioperative-period-100615291",false,"NCT07290699","Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period","INtensive Cholesterol-Lowering With recatIcimab combiNation in Emergency PCI for Acute Myocardial Infarction: A Randomized Controlled Trial","INCLINE-AMI","Inclusion Criteria:\n\n* Age ≥18 years;\n* Meet the definition of acute myocardial infarction according to the \"2019 Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction\", including STEMI and NSTEMI with onset \\\u003C24 hours;\n* Able to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Severe mental disorders that prevent the expression of consent;\n* Severe heart failure (Killip class III or IV) or cardiogenic shock;\n* According to the investigator's judgment, the presence of significant other abnormal signs, laboratory findings, or clinical conditions (such as tumors, shock, liver or kidney failure, etc.) that make participation unsuitable;\n* Investigator's judgment that the subject cannot complete long-term follow-up;\n* Intolerance to statins or cholesterol absorption inhibitors;\n* Intolerance to injections;\n* Subjects who received PCSK9 inhibitor treatment or participated in other PCSK9 inhibitor studies within 4 months before randomization;\n* Pregnant women.","ALL","18 Years",{"count":61,"type":62},2442,"ESTIMATED","INTERVENTIONAL",[65],"PHASE4","This project team is conducting a multicenter randomized controlled study, aiming to administer PCSK9 inhibitors subcutaneously as early as possible within 24 hours during the perioperative period of AMI (included \\\u003C24h STEMI and NSTEMI), and subsequently once every 12 weeks for a total of 6 months, followed by step-down therapy according to guideline-recommended lipid-lowering strategies based on LDL-C target levels. The study will evaluate changes in blood lipids and inflammatory markers during hospitalization and at follow-up visits at 1, 3, 6, 9, and 12 months, as well as the incidence of MACE events. Safety will also be assessed, including liver enzymes, kidney function, and other adverse reactions. Compared with conventional treatment, the study will test efficacy and ultimately clarify that early combined use of PCSK9 inhibitors during the perioperative period of AMI patients can safely and effectively reduce LDL-C, control systemic inflammatory responses, and improve the incidence of MACE events.",[68,69],"STEMI - ST Elevation Myocardial Infarction","NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)",[71,22,72],"Acute myocardial infarction","PCSK9 inhibitor","NOT_YET_RECRUITING","2025-12-16",{"date":76,"type":77},"2025-12-18","ACTUAL",{"date":79,"type":62},"2026-01-01",{"date":81,"type":62},"2028-08-30",{"name":5,"class":6}]