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RecruitingPhase 3ACTRN12613001345774

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

Sponsor

Barwon Health - The Geelong Hospital

Enrollment

520 participants

Start Date

Oct 21, 2013

Study Type

Interventional

Conditions

Postoperative Atrial Fibrillation after Cardiac Surgery

Summary

The purpose of this study is to conduct a prospective double blind placebo randomized control trial to evaluate the effect of colchicine in preventing postoperative atrial fibrillation after cardiac surgery.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria11

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

Exclusion Criteria11

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

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Interventions

Colchicine 0.5 mg oral twice daily for 7 days or until discharge (whichever occurs sooner).

Colchicine 0.5 mg oral twice daily for 7 days or until discharge (whichever occurs sooner).

Locations(1)

Barwon Health - Geelong Hospital campus - Geelong

VIC, Australia

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ACTRN12613001345774