[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532683":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":43,"locations":51,"responsibleParty":73,"collaborators":32,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":32,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":32,"enrollmentInfo":85,"targetDuration":32,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":32,"overallStatus":53,"whyStopped":32,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Beijing Anzhen Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Colchicine group","EXPERIMENTAL","Patients are randomized within 48 hours after diagnosis of ACS, and on the day of randomization, eligible patients undergo standard treatment plus colchicine (0.5mg qd from 1st month to 12th month).",[13],"Drug: Colchicine Pill",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Patients are randomized within 48 hours after diagnosis of ACS, and on the day of randomization, eligible patients undergo standard treatment plus placebo (1 tablet qd from 1st month to 12th month).",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Colchicine Pill","Colchicine 0.5mg once daily will be given on the basis of standard treatment of ACS recommended by guidelines",[9],[27],"Colchicine 0.5 MG",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Placebo one tablet once daily will be given on the basis of standard treatment of ACS recommended by guidelines",[15],null,[34,37,40],{"name":35,"affiliation":5,"role":36},"Yujie Zhou, PhD, MD","STUDY_CHAIR",{"name":38,"affiliation":5,"role":39},"Xiaoli Liu, PhD, MD","STUDY_DIRECTOR",{"name":41,"affiliation":5,"role":42},"Xiaoteng Ma, MD","PRINCIPAL_INVESTIGATOR",[44,48],{"name":35,"role":45,"phone":46,"phoneExt":32,"email":47},"CONTACT","8613901330652","azzyj12@163.com",{"name":41,"role":45,"phone":49,"phoneExt":32,"email":50},"8618810616459","maxiaotengai@163.com",[52],{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Beijing","Beijing Municipality","100029","China","CN",{"type":60,"coordinates":61},"Point",[62,63],116.39723,39.9075,{"lat":63,"lon":62},[66,69,70,71],{"name":38,"role":45,"phone":67,"phoneExt":32,"email":68},"8613581633895","liuxl9881@163.com",{"name":41,"role":45,"phone":49,"phoneExt":32,"email":50},{"name":38,"role":42,"phone":32,"phoneExt":32,"email":32},{"name":41,"role":72,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"type":42,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Yujie Zhou","Professor","100532683","treatment-of-acute-coronary-syndromes-with-low-dose-colchicine-100532683",false,"NCT06215989","Treatment of ACuTe Coronary Syndromes With Low-dose colchICine","Treatment of ACuTe Coronary Syndromes With Low-dose colchICine (TACTIC): a Randomised, Double-blinded, Placebo-controlled, Multicentric Trial","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Definite diagnosis of ACS;\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Type 2 myocardial infarction (Patients with symptoms or signs of myocardial ischemia and evidence of increased oxygen demand or decreased supply \\[for example, tachyarrhythmia, hypotension, or anaemia\\] secondary to an alternative pathology and myocardial necrosis are defined as suffering type 2 myocardial infarction. The classification of type 2 myocardial infarction also includes patients with coronary vasospasm, embolism or spontaneous dissection without evidence of atherothrombosis related to coronary artery disease);\n* Valvular heart disease that is considered likely to require surgical intervention;\n* History of non-skin cancer in the past 3 years;\n* Inflammatory bowel disease or chronic diarrhea;\n* History of gastric ulcer or previous gastric bleeding;\n* Neuromuscular diseases or non-transient (At least 2 laboratory tests) creatine kinase levels greater than 3 times the upper limit of the normal range (except those associated with myocardial infarction);\n* Clinically significant non-transient (At least 2 laboratory tests) blood abnormalities(Hemoglobin \\\u003C100g\u002FL or hematocrit \\\u003C 30% or \\> 52% or white blood cell count \\\u003C 3×109\u002FL or platelet count \\\u003C 100×109\u002FL);\n* Estimated glomerular filtration rate (eGFR)\\\u003C30mL\u002Fmin\u002F1.73m2 (based on CKD-EPI formula);\n* Serum alanine aminotransferase and\u002For aspartate aminotransferase levels greater than 2 times the upper limit of the normal range accompanied by serum total bilirubin levels greater than 2 times the upper limit of the normal range or severe liver disease with coagulation disorders(INR\\>1.5)(except for elevated glutamic oxalacetic transaminase associated with myocardial infarction);\n* Decline in cognitive function due to inability to perform basic activities of daily living independently;\n* Drug or alcohol abuse;\n* Other immunosuppressive therapies already in existence or planned;\n* Other causes require long-term colchicine treatment;\n* History of clear or suspected colchicine allergy;\n* Strong CYP3A4 or P-glycoprotein inhibitors (such as cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) have been used and no other alternative drugs can be used.","ALL","18 Years",{"count":86,"type":87},6574,"ESTIMATED","INTERVENTIONAL",[90],"NA","This trial is designed to evaluate whether low-dose colchicine, in addition to standard treatment recommended by guidelines, further reduces the risk of major adverse cardiovascular events in patients with acute coronary syndromes (ACS) through a prospective, randomized, double-blind, placebo-controlled clinical trial.",[93,94,95,96,97],"Acute Coronary Syndrome","Unstable Angina","ST Elevation Myocardial Infarction","Non ST Segment Elevation Myocardial Infarction","Colchicine","2024-10-27",{"date":100,"type":101},"2024-10-30","ACTUAL",{"date":103,"type":101},"2024-09-02",{"date":105,"type":87},"2028-06",{"name":5,"class":6},1]