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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Surgery, Post-pericardiotomy Syndrome, Atrial Fibrillation, Pericardial Effusion, Pleural Effusion

Intervention / Treatment
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* Drug: Colchicine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo 48 to 72 hours before surgery till 1 months after surgery<br>|
| Active Comparator: Colchicine<br>Colchicine | Drug: Colchicine<br>* Colchicine 0.5 mg BID or colchicine 0.5mg (<70kg) 48 to 72 hours before surgery till 1 months after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence | Incidence of the outcomes at 3 months from cardiac surgery | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Tamponade or Need for Pericardiocentesis |  | 3 months | 
| Need for thoracentesis |  | 3 months | 
| Recurrence of the post-pericardiotomy syndrome |  | 3 months | 
| Re-admission |  | 3 months | 
| Overall mortality |  | 3 months | 
| Stroke incidence |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, post-pericardiotomy syndrome, atrial fibrillation, pericardial effusion, pleural effusion, prevention, colchicine