Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation

• Status: Terminated
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Colchicine

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.