COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)
Information source: Maria Vittoria Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Surgery; Post-pericardiotomy Syndrome; Atrial Fibrillation; Pericardial Effusion; Pleural Effusion
Intervention: Colchicine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Maria Vittoria Hospital
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.
Clinical Details
Official title: COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial).
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence
Secondary outcome: Cardiac Tamponade or Need for PericardiocentesisNeed for thoracentesis Recurrence of the post-pericardiotomy syndrome Re-admission Overall mortality Stroke incidence
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
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Cardiology Dpt. Maria Vittoria Hospital, Torino 10141, Italy
Additional Information
Starting date: March 2012
Last updated: June 29, 2014
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