NCT01552187

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Maria Vittoria Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Cardiac Surgery
• Post-pericardiotomy Syndrome
• Atrial Fibrillation
• Pericardial Effusion
• Pleural Effusion

Interventions

Type	Name	Description
DRUG	Colchicine	Colchicine 0.5 mg BID or colchicine 0.5mg (\<70kg) 48 to 72 hours before surgery till 1 months after surgery
DRUG	Placebo	Placebo 48 to 72 hours before surgery till 1 months after surgery

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2012-03-13
• Last updated: 2014-07-01

Locations

1 site across 1 country: Italy