[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523532":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":27,"locations":27,"responsibleParty":36,"collaborators":38,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":27,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":27,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":27,"overallStatus":62,"whyStopped":27,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":27},{"fullName":5,"class":6},"China National Center for Cardiovascular Diseases","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"experimental group","EXPERIMENTAL","intensive lipid lowering therapy",[13,14],"Drug: Tafolecimab","Drug: Statin",{"label":16,"type":17,"description":18,"interventionNames":19},"control group","ACTIVE_COMPARATOR","conventional lipid lowering therapy",[20,14],"Drug: Cholesterol Absorption Inhibitor",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Tafolecimab","The PCSK9 mAb in this study is defined as Tafolecimab 150mg q2w subcutaneously. For the two groups of lipid-lowering regimens, the lipid-lowering drug regimens other than PCSK9 mAb were maintained throughout the study as much as possible in accordance with the guidelines related to blood lipids, provided that no serious safety problems occurred.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Cholesterol Absorption Inhibitor","Cholesterol absorption inhibitors (like Ezetimibe and Hybutimibe) are based on physician decisions, but need to be routinely dosed. Examples of Medications that Meet Study Requirements: Ezetimibe 10mg Po qd.",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Statin","Statin are based on physician decisions, but need to be routinely dosed. Examples of Medications that Meet Study Requirements: Atorvastatin 20mg Po qn, Rosuvastatin 10mg Po qn or Pitavastatin 4mg Po qn.",[16,9],{"type":37,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[39],{"name":40,"class":41},"Innovent Biologics, Inc.","OTHER","100523532","early-initiation-of-tafolecimab-for-patients-with-acute-coronary-syndromeundergoing-percutaneous-coronary-intervention-in-chinese-population-100523532",false,"NCT06096909","Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population","Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population (EMPACT): A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 18 to 75 years;\n* clinical diagnosis with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) ;\n* undergoing PCI\n* baseline LDL-C 1.8 mmol\u002FL 3.4 mmol\u002FL note: NSTE-ACS includes non-ST-elevation myocardial infarction and unstable angina.\n\nExclusion Criteria:\n\n* Severe heart failure (Killip III or IV) or cardiogenic shock;\n* Previous hemorrhagic cerebrovascular disease history;\n* Uncontrolled or recurrent arrhythmic events;\n* poorly controlled hypertension;\n* Severe hepatic and renal insufficiency (ALT\u002FAST\\> 3 times upper limit of normal, eGFR\\\u003C30 ml\u002Fkg\u002F1.73m2, or ongoing dialysis) or creatine kinase elevation\\>5 times upper limit of normal\n* malignant tumor;\n* Intolerance to statins or cholesterol absorption inhibitors;\n* Intolerance to injections;\n* Life expectancy \\\u003C1 year;\n* poor compliance.","ALL","18 Years","75 Years",{"count":53,"type":54},3684,"ESTIMATED","INTERVENTIONAL",[57],"NA","For patients with ACS undergoing PCI, intensive lipid-lowering including PCSK9 monoclonal antibody should be started as soon as possible, that is, lower LDL-C level should be achieved as soon as possible. Compared with conventional lipid-lowering regimen, it is expected that the occurrence of major adverse cardiovascular events can still be reduced after drug discontinuation. Therefore, the optimization strategy of \"for patients with ACS undergoing PCI, intensive lipid-lowering with PCSK9 monoclonal antibody can be started as soon as possible\" is proposed.",[60,61],"Acute Coronary Syndrome","Non ST Segment Elevation Acute Coronary Syndrome","NOT_YET_RECRUITING","2023-10-20",{"date":65,"type":66},"2023-10-24","ACTUAL",{"date":68,"type":54},"2023-11-01",{"date":70,"type":54},"2027-11-01",{"name":5,"class":6}]