COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial) (COPPS-2)
Primary Purpose
Cardiac Surgery, Post-pericardiotomy Syndrome, Atrial Fibrillation
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Colchicine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Surgery focused on measuring cardiac surgery, post-pericardiotomy syndrome, atrial fibrillation, pericardial effusion, pleural effusion, prevention, colchicine
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
Sites / Locations
- Cardiology Dpt. Maria Vittoria Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Colchicine
Arm Description
Placebo
Colchicine
Outcomes
Primary Outcome Measures
Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence
Incidence of the outcomes at 3 months from cardiac surgery
Secondary Outcome Measures
Cardiac Tamponade or Need for Pericardiocentesis
Need for thoracentesis
Recurrence of the post-pericardiotomy syndrome
Re-admission
Overall mortality
Stroke incidence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01552187
Brief Title
COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)
Acronym
COPPS-2
Official Title
COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial).
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maria Vittoria Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Colchicine
Arm Type
Active Comparator
Arm Description
Colchicine
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
Colchicine 0.5 mg BID or colchicine 0.5mg (<70kg) 48 to 72 hours before surgery till 1 months after surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 48 to 72 hours before surgery till 1 months after surgery
Primary Outcome Measure Information:
Title
Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence
Description
Incidence of the outcomes at 3 months from cardiac surgery
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Cardiac Tamponade or Need for Pericardiocentesis
Time Frame
3 months
Title
Need for thoracentesis
Time Frame
3 months
Title
Recurrence of the post-pericardiotomy syndrome
Time Frame
3 months
Title
Re-admission
Time Frame
3 months
Title
Overall mortality
Time Frame
3 months
Title
Stroke incidence
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cardiology Dpt. Maria Vittoria Hospital
City
Torino
ZIP/Postal Code
10141
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
25172965
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.
Results Reference
derived
PubMed Identifier
23816016
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.
Results Reference
derived
Learn more about this trial
COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)
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