drugset / Trial / NCT02177266
Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colchicine | Small molecule | 0.6 mg | — |