Colchicine for the Primary Prevention of Atrial Fibrillation after Cardiac Surgery: A Double Blind Placebo Randomised Controlled Trial

Barwon Health - The Geelong Hospital0 个研究点目标入组 520 人开始时间: 2013年12月9日最近更新: 2020年1月13日

试验速览

暂无简介。

•1. Isolated CABG
•2. Isolated AVR
•3. CABG and AVR
•4. Able and willing to give informed consent
•5. Able to comply with study procedures
•6. No prior history of paroxysmal, persistent, permanent AF
•7. In sinus rhythm at time of randomization
•8. eGFR greater or equal to 35 ml/min at time of randomisation
•9. Liver Transaminase (AST or ALT) less than 3 times the upper limit of normal at time of randomisation.
•10. Extubated within 72 hours post-operatively and able to tolerate oral intake
•11. Age older than 18 years

•1. Known hypersensitivity to colchicine
•2. Current treatment with colchicine
•3. Known severe liver disease or current transaminases greater than three times the upper normal limit
•4. Current eGFR less than 35 ml/min
•5. Known myopathy or elevated baseline preoperative creatinine kinase (CK) not attributable to their medical condition
•6. Known blood dyscrasias with abnormal preoperative Full Blood Examination (FBE) not attributable to their medical condition
•7. Known severe gastrointestinal disease
•8. Pregnant women, lactating women, or women of childbearing age.
•9. Patients with known paroxysmal, persistent, or chronic AF
•10. Patients extubated after 72 hours of their ICU admission post-operatively
•11. Unable to tolerate oral intake

发起方

Barwon Health - The Geelong Hospital