[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537528":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":32,"locations":42,"responsibleParty":62,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":25,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Cantonal Hospital of St. Gallen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Colchicine","EXPERIMENTAL","The first dose of the IMP is administered in the evening prior to the surgical procedure. Administrations of the study drug follow a 1-0-1 schedule (colchicine 0.5 mg per intake). The last study drug is administered in the evening of the third postoperative day.",[13],"Drug: Colchicine",{"label":15,"type":16,"description":17,"interventionNames":18},"Control (Placebo)","PLACEBO_COMPARATOR","Patients in the control group will receive the same perioperative anaesthetic, surgical and medical treatment as patients in the experimental group, the sole difference being that patients will be given a placebo instead of the IMP colchicine.\n\nThe first dose of the placebo is administered in the evening prior to the surgical procedure. Administrations of the placebo follow a 1-0-1 schedule. The last placebo is administered in the evening of the third postoperative day.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Colchicine Group:\n\nIMP = Colchicine (0.5 mg, enteral) first application in the evening before day of surgery, following a 1-0-1 regimen until the third postoperative day, ending with the application of the ninth dose. Colchicine tablets are provided as 1 mg tablets with a score, which must be divided before ingestion.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Placebo","Placebo Group:\n\nPlacebo (identical to IMP in appearance and application) first application in the evening before day of surgery, following a 1-0-1 regimen until the third postoperative day, ending with the application of the ninth dose. Placebo tablets are provided as tablets with a score, which must be divided before ingestion.",[15],[31],"Control",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":25,"email":37},"Timur Yurttas, MD","CONTACT","0041 714949158","timur.yurttas@kssg.ch",{"name":39,"role":35,"phone":40,"phoneExt":25,"email":41},"Miodrag Filipovic, Prof. MD.","0041714941111","miodrag.filipovic@kssg.ch",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Cantonal Hospital St. Gallen","RECRUITING","Sankt Gallen","Canton of St. Gallen","9007","Switzerland","CH",{"type":52,"coordinates":53},"Point",[54,55],9.37477,47.42391,{"lat":55,"lon":54},[58,60],{"name":34,"role":35,"phone":59,"phoneExt":25,"email":37},"0041714949158",{"name":34,"role":61,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Dr. Timur Yurttas","Principal Investigator, Senior Anaesthesiologist","100537528","phase-3-colchicine-in-patients-at-cardiac-risk-undergoing-major-non-cardiac-surgery-100537528",false,"NCT06279000","Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery","Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery: Prospective, Randomized, Double-blinded, Placebo-controlled, Multi-centre Study","COLCAT","Inclusion Criteria:\n\nundergoing major non-cardiac surgery in general anaesthesia will be included. Major non-cardiac surgery is defined as:\n\n* vascular surgery (with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies)\n* intraperitoneal surgery\n* intrathoracic surgery\n* major orthopaedic surgery (spinal surgery or joint replacement surgery)\n* at cardiovascular risk, defined as meeting at least 1 of the following 6 criteria:\n\n  * preoperative n-terminal pro brain natriuretic peptide (NT-proBNP) ≥ 200 ng\u002Fl\n  * history of coronary artery disease\n  * history of peripheral vascular disease\n  * history of stroke\n  * undergoing major vascular surgery, with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies\n  * fulfilment of any 3 of the 8 following criteria:\n\n    * undergoing major surgery (intrathoracic, intraperitoneal or supra-inguinal vascular surgery)\n    * any history of congestive heart failure or history of pulmonary oedema\n    * anamnestic transient ischemic attack (TIA)\n    * diabetes under treatment with either oral antidiabetic agent or insulin\n    * age \\> 70 years\n    * history of hypertension\n    * serum creatinine \\> 175 mumol\u002Fl or calculated creatinine clearance \\< 60 ml\u002Fmin\u002F1.73m2 (cockcroft gault)\n    * history of smoking within 2 years of surgery\n    * planned surgical time ≥ 90 minutes\n    * planned postoperative hospital stay at least 1 night\n\nExclusion Criteria:\n\n* no written consent\n* inclusion in other clinical trial with direct impact on perioperative medication\n* previously reported side effects or reported intolerance from colchicine (e.g., allergic reaction or significant sensitivity to colchicine or an auxiliary substance of the IMP)\n* pregnancy or planned pregnancy and\u002For breast feeding\n* clinically significant history of drug or alcohol abuse within the last year\n* very severe frailty (≥ 8 clinical frailty scale)\n* patient with inflammatory bowel disease (e.g., Morbus Crohn or Colitis ulcerosa)\n* patient taking colchicine for other indications (e.g., familial Mediterranean fever, gout)\n* severe renal impairment (eGFR \\< 30 ml min -1 1.73 m2 -1) or end-stage renal disease with indication for haemodialysis\n* history of solid organ or bone marrow transplantation\n* systemic immune-suppression (medication (steroids \\>30mg cortisol-equivalent per day, tacrolimus etc...) or disease (e.g., myelodysplastic syndrome)\n* severe hepatic impairment with history of cirrhosis\n* chronic active hepatitis or functional disorders defined as alanine aminotransferase greater than three times the upper limit of normal\n* anticipated post-operative administration of CYP3A4 metabolized substances like cyclosporine, ketoconazole, clarithromycin, verapamil, quinidine, diltiazem or ritonavir\n* Any other condition that the investigator would consider a risk to the patient if the latter were to participate in the study.",true,"ALL","45 Years",{"count":77,"type":78},880,"ESTIMATED","INTERVENTIONAL",[81],"PHASE3","Perioperative myocardial injury and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery.\n\nHowever, research in recent years has yielded limited preventive and therapeutic measures for myocardial injury\u002FMACE. Recent studies in patients with chronic and acute coronary artery disease have shown that colchicine administration can reduce the risk of cardiovascular events.\n\nThese encouraging results in non-surgical patients ask for a similar investigation in patients undergoing major non-cardiac surgery. The aim of the proposed study is to investigate the effects of perioperative colchicine administration on the incidence of myocardial injury\u002FMACE.",[84,85,86,87,88],"Cardiovascular Diseases","Cardiovascular Complication","Perioperative Complication","Myocardial Injury","Myocardial Injury After Noncardiac Surgery (MINS)",[90,91,92,93],"Perioperative Cardiovascular Risk","myocardial injury","major adverse cardiac events","colchicine","2025-04-19",{"date":96,"type":97},"2025-04-24","ACTUAL",{"date":99,"type":97},"2025-04-20",{"date":101,"type":78},"2029-03-30",{"name":5,"class":6},1]