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

Purpose

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	Intervention	Phase
Cardiac Surgery Post-pericardiotomy Syndrome Atrial Fibrillation Pericardial Effusion Pleural Effusion	Drug: Colchicine Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial).

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Pericardial Disorders

Drug Information available for: Colchicine

U.S. FDA Resources

Further study details as provided by Maria Vittoria Hospital:

Primary Outcome Measures:

Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Incidence of the outcomes at 3 months from cardiac surgery

Secondary Outcome Measures:

Cardiac Tamponade or Need for Pericardiocentesis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Need for thoracentesis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Recurrence of the post-pericardiotomy syndrome [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Re-admission [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Overall mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Stroke incidence [ Time Frame: 3 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	360
Study Start Date:	March 2012
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552187

Locations


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

Sponsors and Collaborators

Maria Vittoria Hospital

More Information

No publications provided by Maria Vittoria Hospital

Additional 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
Study First Received:	March 6, 2012
Last Updated:	June 29, 2014
Health Authority:	Italy: Ministry of Health

Keywords provided by Maria Vittoria Hospital:


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

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 27, 2015