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

Phase 3

Recruiting

• Conditions: Postoperative Atrial Fibrillation after Cardiac Surgery; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12613001345774
• Lead Sponsor: Barwon Health - The Geelong Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified