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

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ClinicalTrials.gov Identifier: NCT01552187
Recruitment Status : Unknown
Verified June 2014 by Massimo Imazio, Maria Vittoria Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 13, 2012
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Massimo Imazio, 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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Post-pericardiotomy Syndrome Atrial Fibrillation Pericardial Effusion Pleural Effusion Drug: Colchicine Drug: Placebo Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial).
Study Start Date : March 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo 48 to 72 hours before surgery till 1 months after surgery
Active Comparator: Colchicine
Colchicine
Drug: Colchicine
Colchicine 0.5 mg BID or colchicine 0.5mg (<70kg) 48 to 72 hours before surgery till 1 months after surgery



Primary Outcome Measures :
  1. Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence [ Time Frame: 3 months ]
    Incidence of the outcomes at 3 months from cardiac surgery


Secondary Outcome Measures :
  1. Cardiac Tamponade or Need for Pericardiocentesis [ Time Frame: 3 months ]
  2. Need for thoracentesis [ Time Frame: 3 months ]
  3. Recurrence of the post-pericardiotomy syndrome [ Time Frame: 3 months ]
  4. Re-admission [ Time Frame: 3 months ]
  5. Overall mortality [ Time Frame: 3 months ]
  6. Stroke incidence [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552187


Locations
Italy
Cardiology Dpt. Maria Vittoria Hospital
Torino, Italy, 10141
Sponsors and Collaborators
Maria Vittoria Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Massimo Imazio, Principal Investigator, Maria Vittoria Hospital
ClinicalTrials.gov Identifier: NCT01552187     History of Changes
Other Study ID Numbers: 86/19/11
2011-005835-21 ( EudraCT Number )
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014

Keywords provided by Massimo Imazio, Maria Vittoria Hospital:
cardiac surgery
post-pericardiotomy syndrome
atrial fibrillation
pericardial effusion
pleural effusion
prevention
colchicine

Additional relevant MeSH terms:
Syndrome
Atrial Fibrillation
Pleural Effusion
Pericardial Effusion
Postpericardiotomy Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pleural Diseases
Respiratory Tract Diseases
Postoperative Complications
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents