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 because the information has not been verified recently.
Verified June 2014 by Maria Vittoria Hospital.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Maria Vittoria Hospital
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
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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:
Genetics Home Reference related topics:
familial atrial fibrillation
Drug Information available for:
Colchicine
U.S. FDA Resources
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 (Adult, Senior) |
| 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
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
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:
|
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 |
ClinicalTrials.gov processed this record on September 23, 2016