This trial is active, not recruiting.

Conditions cardiac surgery, post-pericardiotomy syndrome, atrial fibrillation, pericardial effusion, pleural effusion
Treatments colchicine, placebo
Phase phase 3
Sponsor Maria Vittoria Hospital
Start date March 2012
End date June 2014
Trial size 360 participants
Trial identifier NCT01552187, 2011-005835-21, 86/19/11


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
(Placebo Comparator)
Placebo 48 to 72 hours before surgery till 1 months after surgery
(Active Comparator)
Colchicine 0.5 mg BID or colchicine 0.5mg (<70kg) 48 to 72 hours before surgery till 1 months after surgery

Primary Outcomes

Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence
time frame: 3 months

Secondary Outcomes

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
time frame: 3 months
Overall mortality
time frame: 3 months
Stroke incidence
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial).
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Maria Vittoria Hospital.