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

Last updated: June 29, 2014
Sponsor: Maria Vittoria Hospital
Overall Status: Trial Status Unknown

Phase

3

Condition

Chest Pain

Cardiac Disease

Lung Disease

Treatment

N/A

Clinical Study ID

NCT01552187
86/19/11
2011-005835-21
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18years

  • Candidate to cardiac surgery but cardiac transplantation

  • Informed consent

Exclusion

Exclusion Criteria:

  • Atrial fibrillation

  • Candidate to cardiac transplantation

  • Severe liver disease or elevation of serum transaminases (> 1.5 times the upperreference 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 acontraception method

  • Hypersensitivity to colchicine

  • Treatment with colchicine for any cause

Study Design

Total Participants: 360
Study Start date:
March 01, 2012
Estimated Completion Date:
July 31, 2014

Study 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.

Connect with a study center

  • Cardiology Dpt. Maria Vittoria Hospital

    Torino, 10141
    Italy

    Site Not Available

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