TerminatedPhase 3

Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation

Stopped: Difficulty in recruiting patients

United States2 participantsStarted 2015-05

Plain-language 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.

Who can participate

Age range40 Years

SexALL

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

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. * Inabi…

What they're measuring

Number of Patients With Post Cardiac Surgery Atrial Fibrillation or Post-pericardiotomy Syndrome.

Timeframe: Baseline to 3 months

Trial details

NCT IDNCT02177266

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11

Results submitted2017-05-24