Atrial Fibrillation Clinical Trial
Official title:
Colchicine Versus Placebo in Post-Cardiac Surgery Patients to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation
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.
Background. Patients undergoing cardiac surgery are at risk for post-pericardiotomy syndrome
and post-operative atrial fibrillation. It is unknown whether post-pericardiotomy syndrome
predisposes patients to constrictive pericarditis, but cardiac surgery is currently the most
common cause of constrictive pericarditis. A multicenter European study demonstrated that
Colchicine is a promising treatment to help prevent the development of pericardial
effusions, atrial fibrillation and post-pericardiotomy syndrome (Imazio et al, Circulation
2011;124:2290-5). However, Colchicine is not routinely given to patients after a cardiac
surgery and the impact of Colchicine on post-operative atrial fibrillation and constrictive
pericarditis have not been studied in the United States.
Methods. This is a randomized, double-blinded placebo controlled study for patients
undergoing cardiac surgery to determine if Colchicine in comparison to placebo is effective
in preventing the development of post-operative atrial fibrillation, post-pericardiotomy
syndrome and constrictive physiology. The investigators will randomize 278 adults prior to
undergoing cardiac surgery for CABG or aortic valve disease to receive either placebo or
Colchicine 0.6mg bid for one month starting 48-72 hours preoperatively. The investigators
will follow participants for 3 months to determine the development of a post-pericardiotomy
syndrome. In addition, post-operative atrial fibrillation will be determined based on
continuous telemetry from operation up to 5 days prior to hospital discharge and after
discharge by using remote telemetry monitoring with BodyGuardianTM. C-reactive protein (CRP)
will be obtained prior to hospital discharge and at 3 month follow-up. Echocardiography will
be done initially in the post-operative course prior to hospital discharge and then again at
3 months to assess for the presence of pericardial effusion, diastolic dysfunction, left
atrial enlargement and constrictive physiology. The presence of pleural effusion will be
done by echocardiogram.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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