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

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

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

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
Italy | |
Cardiology Dpt. Maria Vittoria Hospital | |
Torino, Italy, 10141 |
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 |