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Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Jae Oh, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20111685

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