COlchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery - COP-AF

Population Health Research Institute0 个研究点目标入组 2,800 人开始时间: 2020年10月7日最近更新: 2021年1月11日

适应症

试验速览

暂无简介。

•All patients undergoing thoracic surgery with general anesthesia are eligible for the trial if they are =55 years of age at the time of randomization and expected to require at least an overnight hospital
•admission after surgery.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 980
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1820

•1. patients with a prior history of documented AF;
•2. patients currently taking anti-arrhythmic medication other than ß-blockers, calcium channels blockers or digoxin;
•3. patients undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies);
•4. patients with contraindications to colchicine (i.e., allergy to colchicine, myelodysplastic disorders, or an estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m);
•5. patients not expected to take oral medications for >24 hours after surgery (e.g., esophagectomy);
•6. patients scheduled for lung transplantation;
•7. patients currently taking non-study colchicine before surgery;
•8. patients with severe hepatic dysfunction;
•9. patients with aplastic anemia;
•10. women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding;
•11. patients who took within the last 14 days or scheduled to take during the first 10 days after surgery clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole, or itraconazole during the
•first 10 days after surgery; OR
•12. HIV patients treated with antiretroviral therapy;

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