TerminatedPhase 3

Effect of Low Dose ColchiciNe on the InciDence of POAF

Stopped: Statistical analysis of interim data showed no advantage of colchicine

Jordan254 participantsStarted 2017-10-02

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Atrial fibrillation

Timeframe: Through study completion, an average of 1 week

Trial details

NCT IDNCT03015831

SponsorJordan Collaborating Cardiology Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-01

View on ClinicalTrials.gov More Atrial Fibrillation trials