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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Massimo Imazio, Maria Vittoria Hospital
ClinicalTrials.gov Identifier:
NCT01552187
First received: March 6, 2012
Last updated: June 29, 2014
Last verified: June 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Maria Vittoria Hospital:

Primary Outcome Measures:
  • Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Incidence of the outcomes at 3 months from cardiac surgery


Secondary Outcome Measures:
  • Cardiac Tamponade or Need for Pericardiocentesis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Need for thoracentesis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Recurrence of the post-pericardiotomy syndrome [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Re-admission [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Overall mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Stroke incidence [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552187

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

No publications provided by Maria Vittoria Hospital

Additional 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
Study First Received: March 6, 2012
Last Updated: June 29, 2014
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 23, 2014