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 range

18 Years – 99 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

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