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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Massimo Imazio, Maria Vittoria Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552187
First Posted: March 13, 2012
Last Update Posted: July 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Massimo Imazio, Maria Vittoria Hospital
  Purpose
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 Intervention Phase
Cardiac Surgery Post-pericardiotomy Syndrome Atrial Fibrillation Pericardial Effusion Pleural Effusion Drug: Colchicine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by Massimo Imazio, Maria Vittoria Hospital:

Primary Outcome Measures:
  • 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:
  • Cardiac Tamponade or Need for Pericardiocentesis [ Time Frame: 3 months ]
  • Need for thoracentesis [ Time Frame: 3 months ]
  • Recurrence of the post-pericardiotomy syndrome [ Time Frame: 3 months ]
  • Re-admission [ Time Frame: 3 months ]
  • Overall mortality [ Time Frame: 3 months ]
  • Stroke incidence [ Time Frame: 3 months ]

Estimated Enrollment: 360
Study Start Date: March 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
  Contacts and Locations
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
  More Information

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 Submitted: March 6, 2012
First Posted: March 13, 2012
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


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