Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Atrial Fibrillation, Post-pericardiotomy Syndrome, Constriction
In brief
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.
Key facts
- Study ID
- NCT02177266
- Run by
- Mayo Clinic
- People needed
- 2
- Starts
- 2015-05-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2017-06-21
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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