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

Phase 3

• Conditions: Cardiac Surgery; Post-pericardiotomy Syndrome; Atrial Fibrillation; Pericardial Effusion; Pleural Effusion
• Interventions: Drug: Placebo; Drug: Colchicine

• Registration Number: NCT01552187
• Lead Sponsor: Maria Vittoria Hospital

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 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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-13
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Last Update Submitted: 2014-06-29
• Study Completion: 2014-07
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Colchicine	Colchicine	Colchicine

Primary Outcome Measures

Name	Time	Method
Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence	3 months	Incidence of the outcomes at 3 months from cardiac surgery

Secondary Outcome Measures

Name	Time	Method
Cardiac Tamponade or Need for Pericardiocentesis	3 months
Need for thoracentesis	3 months
Re-admission	3 months
Overall mortality	3 months
Stroke incidence	3 months
Recurrence of the post-pericardiotomy syndrome	3 months

Trial Locations

Locations (1)

Cardiology Dpt. Maria Vittoria Hospital; 🇮🇹 Torino, Italy