[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577470":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":69,"collaborators":44,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":44,"enrollmentInfo":81,"targetDuration":44,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":44,"overallStatus":52,"whyStopped":44,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Tomsk Cardiology Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","Standard technique without performing the pericardial fenestration procedure intraoperatively. Standard postoperative treatment",[13],"Drug: NSAID",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental group","EXPERIMENTAL","Pericardial fenestration during coronary artery bypass grafting using the original technique.\n\nColchicine (Colchicum-dispert) administration 4 hours before surgery and for 10 days after surgery",[19],"Drug: Colchicine 0.5 MG",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","NSAID","standard CABG without performing pericardial fenestration intraoperatively",[9],[27],"non-steroidal anti-inflammatory drugs",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Colchicine 0.5 MG","Colchicine will be prescribed in a dose of 500 micrograms 4 hours before surgery and 500 micrograms 2 times a day for 10 days after surgery with pericardial fenestration",[15],[33],"Colchicum-dispert",[35],{"name":36,"affiliation":37,"role":38},"Yuri Y Vechersky, PhD","Cardiology Research Institute, Tomsk National Research Medical Center","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Mariia L Diakova, PhD","CONTACT","+79039155049",null,"prima.maria@mail.ru",{"name":36,"role":42,"phone":47,"phoneExt":44,"email":48},"+79039512225","vjj@cardio-tomsk.ru",[50],{"facility":51,"status":52,"city":53,"state":44,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia","RECRUITING","Tomsk","634012","Russia","RU",{"type":58,"coordinates":59},"Point",[60,61],84.98216,56.50049,{"lat":61,"lon":60},[64,66,67],{"name":65,"role":42,"phone":43,"phoneExt":44,"email":45},"Maria V Diakova, PhD",{"name":36,"role":42,"phone":47,"phoneExt":44,"email":48},{"name":65,"role":68,"phone":44,"phoneExt":44,"email":44},"SUB_INVESTIGATOR",{"type":70,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100577470","phase-4-the-effect-of-colchicine-on-the-occurrence-of-atrial-fibrillation-after-cardiac-surgery-100577470",false,"NCT06798714","The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery","The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery (CAFE)","CAFE","Inclusion Criteria:\n\n1. Elective coronary artery bypass grafting on pump;\n2. signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Reduced left ventricular ejection fraction (≤35%);\n2. Valvular heart disease requiring surgical correction;\n3. Liver failure with an increase in liver transaminases ≥1.5 times;\n4. Renal failure (GFR\\\u003C35 mL\u002Fmin\u002F1.73 m2 calculated with CKD-EPI);\n5. Permanent, persistent or paroxysmal atrial fibrillation;\n6. Previously implanted pacemaker;\n7. Hypersensitivity to colchicine;\n8. Neutropenia;\n9. History of alcoholism;\n10. Refusal to sign informed consent","ALL","18 Years",{"count":82,"type":83},140,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","Development of a new comprehensive method for perioperative prevention of atrial fibrillation paroxysms in cardiac surgery patients at the hospital stage.\n\nIt is planned to recruit 70 patients who will undergo pericardial fenestration during the operation using the original technique during coronary artery bypass grafting (Patent No. 2647626 C1 Russian Federation), and will be prescribed colchicine (the drug \"Colchicum-dispert\") in the perioperative period in order to prevent the development of paroxysms of atrial fibrillation in the postoperative period, and 70 cardiac surgery patients operated on using the standard technique (without performing the pericardial fenestration procedure intraoperatively), receiving non-steroidal anti-inflammatory drugs in the postoperative period.",[89,90,91,92],"Coronary Artery Disease","Atrial Fibrillation","Coronary Artery Bypass Grafting","Colchicine","2025-09-02",{"date":95,"type":96},"2025-09-09","ACTUAL",{"date":98,"type":96},"2025-01-20",{"date":100,"type":83},"2026-02-20",{"name":5,"class":6},1]