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

Study Status: Enrolling by invitation
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 ]

Incidence of the outcomes at 3 months from cardiac surgery


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