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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Primary Outcome Measures :

1. 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 :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Maria Vittoria Hospital

More Information

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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
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