COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial) (COPPS-2)

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ClinicalTrials.gov Identifier: NCT01552187

Recruitment Status : Unknown

Verified June 2014 by Massimo Imazio, Maria Vittoria Hospital.
Recruitment status was: Active, not recruiting

First Posted : March 13, 2012

Last Update Posted : July 1, 2014

Sponsor:

Information provided by (Responsible Party):

Massimo Imazio, Maria Vittoria Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiac Surgery Post-pericardiotomy Syndrome Atrial Fibrillation Pericardial Effusion Pleural Effusion	Drug: Colchicine Drug: Placebo	Phase 3

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	360 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial).
Study Start Date :	March 2012
Estimated Primary Completion Date :	June 2014
Estimated Study Completion Date :	July 2014

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Colchicine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo 48 to 72 hours before surgery till 1 months after surgery
Active Comparator: Colchicine Colchicine	Drug: Colchicine Colchicine 0.5 mg BID or colchicine 0.5mg (<70kg) 48 to 72 hours before surgery till 1 months after surgery

Outcome Measures

Primary Outcome Measures :

Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence [ Time Frame: 3 months ]
Incidence of the outcomes at 3 months from cardiac surgery

Secondary Outcome Measures :

Cardiac Tamponade or Need for Pericardiocentesis [ Time Frame: 3 months ]
Need for thoracentesis [ Time Frame: 3 months ]
Recurrence of the post-pericardiotomy syndrome [ Time Frame: 3 months ]
Re-admission [ Time Frame: 3 months ]
Overall mortality [ Time Frame: 3 months ]
Stroke incidence [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552187

Locations


Italy
Cardiology Dpt. Maria Vittoria Hospital
Torino, Italy, 10141

Sponsors and Collaborators

Maria Vittoria Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. Review.


Responsible Party:	Massimo Imazio, Principal Investigator, Maria Vittoria Hospital
ClinicalTrials.gov Identifier:	NCT01552187 History of Changes
Other Study ID Numbers:	86/19/11 2011-005835-21 ( EudraCT Number )
First Posted:	March 13, 2012 Key Record Dates
Last Update Posted:	July 1, 2014
Last Verified:	June 2014

Keywords provided by Massimo Imazio, Maria Vittoria Hospital:


cardiac surgery post-pericardiotomy syndrome atrial fibrillation pericardial effusion	pleural effusion prevention colchicine

Additional relevant MeSH terms:


Syndrome Atrial Fibrillation Pleural Effusion Pericardial Effusion Postpericardiotomy Syndrome Disease Pathologic Processes Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pleural Diseases	Respiratory Tract Diseases Postoperative Complications Colchicine Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

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