Clinical trial NCT01552187: COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)
Official title: COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cardiac Surgery
Post-pericardiotomy Syndrome
Atrial Fibrillation
Pericardial Effusion
Pleural Effusion
Keywords: cardiac surgery
post-pericardiotomy syndrome
atrial fibrillation
pericardial effusion
pleural effusion
prevention
colchicine
Lead sponsor: Maria Vittoria Hospital
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a multicenter, double-blind, randomized trial to assess the efficacy and safety of colchicine for post-pericardiotomy syndrome prevention, post-operative effusions prevention, and post-operative atrial fibrillation prevention.

Detailed description: This is a multi center, double-blind, randomized trial to test the efficacy and safety of colchicine for prevention of post-pericardiotomy syndrome, post-operative effusions, and post-operative atrial fibrillation.

Eligibility criteria: Inclusion Criteria:

* Age \> 18years
* Candidate to cardiac surgery but cardiac transplantation
* Informed consent

Exclusion Criteria:

* Atrial fibrillation
* Candidate to cardiac transplantation
* Severe liver disease or elevation of serum transaminases (\> 1.5 times the upper reference limit)
* Serum creatinine \> 2.5 mg/dL
* Preoperative elevation of CK or known myopathy
* Known chronic intestinal diseases or blood dyscrasias
* Pregnancy, Lactation or Women of childbearing potential not protected by a contraception method
* Hypersensitivity to colchicine
* Treatment with colchicine for any cause

Primary outcomes:
measure: Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence
timeFrame: 3 months
Secondary outcomes:
measure: Cardiac Tamponade or Need for Pericardiocentesis
timeFrame: 3 months
measure: Need for thoracentesis
timeFrame: 3 months
measure: Recurrence of the post-pericardiotomy syndrome
timeFrame: 3 months
measure: Re-admission
timeFrame: 3 months
measure: Overall mortality
timeFrame: 3 months
measure: Stroke incidence
timeFrame: 3 months
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Cardiology Dpt. Maria Vittoria Hospital
Study officials:
References:
citation: Imazio M, Brucato A, Ferrazzi P, Pullara A, Adler Y, Barosi A, Caforio AL, Cemin R, Chirillo F, Comoglio C, Cugola D, Cumetti D, Dyrda O, Ferrua S, Finkelstein Y, Flocco R, Gandino A, Hoit B, Innocente F, Maestroni S, Musumeci F, Oh J, Pergolini A, Polizzi V, Ristic A, Simon C, Spodick DH, Tarzia V, Trimboli S, Valenti A, Belli R, Gaita F; COPPS-2 Investigators. Colchicine for prevention of postpericardiotomy syndrome and postoperative atrial fibrillation: the COPPS-2 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1016-23. doi: 10.1001/jama.2014.11026.
citation: Imazio M, Belli R, Brucato A, Ferrazzi P, Patrini D, Martinelli L, Polizzi V, Cemin R, Leggieri A, Caforio AL, Finkelstein Y, Hoit B, Maisch B, Mayosi BM, Oh JK, Ristic AD, Seferovic P, Spodick DH, Adler Y. Rationale and design of the COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 trial): a randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation. Am Heart J. 2013 Jul;166(1):13-9. doi: 10.1016/j.ahj.2013.03.025. Epub 2013 May 6.