Effect of Low Dose ColchiciNe on the InciDence of POAF

• Status: Terminated
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test 0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jordan Collaborating Cardiology Group
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• All patients aged 18 years or above undergoing elective cardiac surgery.

• Sinus rhythm and no previous AF

• Agreed to sign informed consent.

Exclusion Criteria:

• Known severe liver disease or current transaminases >1.5 times the upper normal limit

• Current serum creatinine >2.5 mg/dL

• Known myopathy or elevated baseline preoperative creatine kinase

• Known blood dyscrasias or significant gastrointestinal disease

• Pregnant and lactating women

• Known hypersensitivity to colchicine

• Current treatment with colchicine for any indications

• Emergency surgery