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

Maria Vittoria Hospital

Status and phase

Unknown

Phase 3

Conditions

Pericardial Effusion

Cardiac Surgery

Post-pericardiotomy Syndrome

Atrial Fibrillation

Pleural Effusion

Treatments

Drug: Placebo

Drug: Colchicine

Study type

Interventional

Funder types

Other

Identifiers

NCT01552187

86/19/11

2011-005835-21 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

360 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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