Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation
Condition: Atrial Fibrillation; Post-pericardiotomy Syndrome; Constriction
MeSH terms: Atrial Fibrillation; Postpericardiotomy Syndrome; Syndrome; Constriction, Pathologic
Intervention: Colchicine; Placebo
Intervention description: Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.; The placebo will match the study drug.
Intervention MeSH terms: Colchicine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The study will determine the benefit of Colchicine versus placebo for cardiac surgery
      patients on the post-operative development of atrial fibrillation and post-pericardiotomy
      syndrome.

      Primary Objective. Colchicine will reduce the composite endpoint of incidence of
      post-operative atrial fibrillation and post-pericardiotomy syndrome at 3 months following
      cardiac surgery.

      Secondary Objectives.

        1. Colchicine will reduce the incidence of constrictive physiology on echocardiography at 3
           months following cardiac surgery.

        2. Reduction in the burden of symptomatic and asymptomatic atrial fibrillation in the 3
           months following cardiac surgery with the use of colchicine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All consecutive adult patients (age > 40) undergoing standard (non-minimally invasive)
             coronary artery bypass surgery and/or aortic valve surgery will be approached for
             enrollment.

          -  All patients must be able to provide informed consent and comply with the 3 month
             follow-up.

          -  For women of reproductive capability, contraception is necessary and required.

        Exclusion Criteria:

          -  Epidermal growth factor receptor (eGFR) < 30 mL/min/1.73 m^2, serum creatinine > 2.5
             mg/dL or requiring dialysis

          -  Known permanent or current atrial fibrillation (history of paroxysmal atrial
             fibrillation allowed if in sinus rhythm at present)

          -  Allergy to colchicine or already treated with colchicine.

          -  Known blood dyscrasia (acute or chronic leukemia, pancytopenia, aplastic anemia,
             leukopenia)

          -  Known serious gastrointestinal disease

          -  Known severe liver disease (cirrhosis, aspartate aminotransferase (AST)/alanine
             aminotransferase (ALT) > 2x the upper limit of normal, Model End Stage Liver Disease
             (MELD) score > 20)

          -  Women of childbearing potential not using contraception.

          -  Patients with HIV or AIDS as the use of protease inhibitors can result in serious
             colchicine toxicity.

          -  Patients who are treated with strong CYP3A4 inhibitors (clarithromycin/erythromycin,
             chloramphenicol, ketoconazole/itraconazole, and nefazodone).

          -  There is a risk of rhabdomyolysis with the use of digoxin and colchicine, we will
             exclude patients who require ongoing treatment with digoxin.

          -  Inability or unwillingness of the individual to give written informed consent.