Clinical Trial: COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial).
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 Summary: 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.
Sponsor: Maria Vittoria Hospital
Current Primary Outcome: Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
- Re-admission [ Time Frame: 3 months ]
- Overall mortality [ Time Frame: 3 months ]
- Stroke incidence [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Maria Vittoria Hospital
Dates:
Date Received: March 6, 2012
Date Started: March 2012
Date Completion: July 2014
Last Updated: June 29, 2014
Last Verified: June 2014