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

Information source: Maria Vittoria Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiac Surgery; Post-pericardiotomy Syndrome; Atrial Fibrillation; Pericardial Effusion; Pleural Effusion

Intervention: Colchicine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Maria Vittoria Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence

Secondary outcome:

Cardiac Tamponade or Need for Pericardiocentesis

Need for thoracentesis

Recurrence of the post-pericardiotomy syndrome

Re-admission

Overall mortality

Stroke incidence

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.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

Cardiology Dpt. Maria Vittoria Hospital, Torino 10141, Italy
Additional Information

Starting date: March 2012
Last updated: June 29, 2014

Page last updated: August 20, 2015

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