Effect of Low Dose ColchiciNe on the InciDence of POAF

Study Overview
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Brief Summary
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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.

Detailed Description
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AF after cardiac surgery leads to excess mortality and morbidity. Colchicine was used in several studies to lower the incidence AF but the results were generally disappointing. There was no benefit in reducing AF and there was a high incidence of GI side effects especially diarrhea, often leading to stopping the medication. However, a recently published meta-analysis showed that colchicine reduced AF, but again warned of the high incidence of GI side effects. The maintenance dose of colchicine used in these studies was 1 mg daily it is hypothesized that low dose colchicine (0.5 not 1 mg colchicine) might lower AF after cardiac surgery without the prohibitive GI side effects Patients will be randomized to colchicine vs. placebo started the day before surgery and continued until hospital discharge. The primary efficacy endpoint will be the incidence of AF. The primary safety endpoint will be the GI side effects

Official Title
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Effect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients

Conditions
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Atrial Fibrillation, Cardiac Surgery, Colchicine Adverse Reaction

Intervention / Treatment
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* Drug: Colchicine
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Colchicine<br>Intervention by administering an active copmarator of 1 mg colchicine one day pre op and 0.5 mg daily after surgery until discharge | Drug: Colchicine<br>* Colchicine will be given to open heart surgery patients<br>* Other names: Colcrys, Mitigare;|
| Placebo Comparator: Placebo Oral Tablet<br>Identical tablet (placebo) administered in a similar way as that in the active comparator arm | Drug: Placebo Oral Tablet<br>* Placebo Oral Tablet will be given to open heart surgery patients according to randomization<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation | AF documented by EKG | Through study completion, an average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of colchicine | Gastrointestinal side effects | Through study completion, an average of 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Cardiac surgery, Colchicine