drugset / Trial / NCT02177266

Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation

NCT02177266

Phase 3 Terminated 2 enrolled Mayo Clinic
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-05
Primary completion
2016-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 0.6 mg

Indications