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

• Status: Unknown status
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Vittoria Hospital
• Treatments: Colchicine

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