Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation

Overview

About this study

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.

Colchicine will reduce the incidence of constrictive physiology on echocardiography at 3 months following cardiac surgery.
Reduction in the burden of symptomatic and asymptomatic atrial fibrillation in the 3 months following cardiac surgery with the use of colchicine.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

The study population will consist participants enrolled at the Mayo Clinic, Rochester Minnesota.

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

All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation:

eGFR < 30 mL/min/1.73 m2, 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, AST/ALT > 2x the upper limit of normal, 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/erythyromycin, 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Jae Oh, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Jae Oh, M.D.

Closed for enrollment

More information

Publications

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