Cardiac SurgeryPhase 3COPPS-2NCT01552187
COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)
A Phase 3 study testing Colchicine in people with Cardiac Surgery and Post-pericardiotomy Syndrome, run by Maria Vittoria Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Surgery, Post-pericardiotomy Syndrome, Atrial Fibrillation
- What is being tested?
- Colchicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Jul 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18years
- Candidate to cardiac surgery but cardiac transplantation
- Informed consent
Who cannot join
- 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
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- Pregnancy, Lactation or Women of childbearing potential not protected by a contraception method
- Hypersensitivity to colchicine
- Treatment with colchicine for any cause
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial).
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.
Read the 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.
- Conditions
- Cardiac Surgery, Post-pericardiotomy Syndrome, Atrial Fibrillation, Pericardial Effusion, Pleural Effusion
- Being tested
- Colchicine, Placebo
- Keywords
- cardiac surgery, post-pericardiotomy syndrome, atrial fibrillation, pericardial effusion, pleural effusion, prevention, colchicine
- Medical subject headings
- Postpericardiotomy Syndrome, Atrial Fibrillation, Pericardial Effusion, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine 0.5 mg BID or colchicine 0.5mg (<70kg) 48 to 72 hours before surgery till 1 months after surgery
PlaceboDrug
Placebo 48 to 72 hours before surgery till 1 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Colchicine | Active comparator | Colchicine Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence
Incidence of the outcomes at 3 months from cardiac surgery
Measured: 3 months
Secondary outcomes (6)
Cardiac Tamponade or Need for Pericardiocentesis
Measured: 3 months
Need for thoracentesis
Measured: 3 months
Recurrence of the post-pericardiotomy syndrome
Measured: 3 months
Re-admission
Measured: 3 months
Overall mortality
Measured: 3 months
Stroke incidence
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Vittoria Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Imazio, Maria Vittoria Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552187
- Sponsor's protocol ID
- 86/19/11
- Other IDs
- 2011-005835-21
- Acronym
- COPPS-2
- Status last verified
- Jun 2014
- First submitted
- 6 Mar 2012
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Imazio M, Brucato A, Ferrazzi P, Pullara A, Adler Y, Barosi A, Caforio AL, Cemin R, Chirillo F, Comoglio C, Cugola D, Cumetti D, Dyrda O, Ferrua S, Finkelstein Y, Flocco R, Gandino A, Hoit B, Innocente F, Maestroni S, Musumeci F, Oh J, Pergolini A, Polizzi V, Ristic A, Simon C, Spodick DH, Tarzia V, Trimboli S, Valenti A, Belli R, Gaita F; COPPS-2 Investigators. Colchicine for prevention of postpericardiotomy syndrome and postoperative atrial fibrillation: the COPPS-2 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1016-23. doi: 10.1001/jama.2014.11026.
PubMed 25172965Imazio M, Belli R, Brucato A, Ferrazzi P, Patrini D, Martinelli L, Polizzi V, Cemin R, Leggieri A, Caforio AL, Finkelstein Y, Hoit B, Maisch B, Mayosi BM, Oh JK, Ristic AD, Seferovic P, Spodick DH, Adler Y. Rationale and design of the COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 trial): a randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation. Am Heart J. 2013 Jul;166(1):13-9. doi: 10.1016/j.ahj.2013.03.025. Epub 2013 May 6.
PubMed 23816016
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial).
- ClinicalTrials.gov ID
- NCT01552187
- Acronym / sponsor ID
- COPPS-2 / 86/19/11
- Conditions
- Cardiac Surgery, Post-pericardiotomy Syndrome, Atrial Fibrillation, Pericardial Effusion, Pleural Effusion
- Keywords
- cardiac surgery, post-pericardiotomy syndrome, atrial fibrillation, pericardial effusion, pleural effusion, prevention, colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Maria Vittoria HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Colchicine | Active comparator | Drug: ColchicineColchicine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18years
- Candidate to cardiac surgery but cardiac transplantation
- Informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineColchicine 0.5 mg BID or colchicine 0.5mg (<70kg) 48 to 72 hours before surgery till 1 months after surgery | Drug | Colchicine |
| PlaceboPlacebo 48 to 72 hours before surgery till 1 months after surgery | Drug | Placebo |
Primary outcome
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
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- Derived from this study: PubMed 25172965Imazio M, Brucato A, Ferrazzi P, Pullara A, Adler Y, Barosi A, Caforio AL, Cemin R, Chirillo F, Comoglio C, Cugola D, Cumetti D, Dyrda O, Ferrua S, Finkelstein Y, Flocco R, Gandino A, Hoit B, Innocente F, Maestroni S, Musumeci F, Oh J, Pergolini A, Polizzi V, Ristic A, Simon C, Spodick DH, Tarzia V, Trimboli S, Valenti A, Belli R, Gaita F; COPPS-2 Investigators. Colchicine for prevention of postpericardiotomy syndrome and postoperative atrial fibrillation: the COPPS-2 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1016-23. doi: 10.1001/jama.2014.11026.
- Derived from this study: PubMed 23816016Imazio M, Belli R, Brucato A, Ferrazzi P, Patrini D, Martinelli L, Polizzi V, Cemin R, Leggieri A, Caforio AL, Finkelstein Y, Hoit B, Maisch B, Mayosi BM, Oh JK, Ristic AD, Seferovic P, Spodick DH, Adler Y. Rationale and design of the COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 trial): a randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation. Am Heart J. 2013 Jul;166(1):13-9. doi: 10.1016/j.ahj.2013.03.025. Epub 2013 May 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine in people with Cardiac Surgery and Post-pericardiotomy Syndrome, run by Maria Vittoria Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01552187, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.