Postpericardiotomy SyndromePhase 3NCT00128427
Study of Colchicine to Prevent the Postpericardiotomy Syndrome
A Phase 3 study testing Colchicine (for 1 month) in people with Postpericardiotomy Syndrome, run by Azienda Sanitaria Locale 3, Torino at 6 sites in Italy.
Trial summary
The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postpericardiotomy Syndrome
- What is being tested?
- Colchicine (for 1 month)
- How many people
- 360 participants
- Where
- 6 sitesItaly
- Study dates
- Jun 2005to Jun 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in the third day after a cardiac surgery operation
- Age≥ 18 years
- Informed consent
Who cannot join
- All evaluated before the surgical operation:
- Known severe liver disease and/or elevated transaminases >1.5 times the upper limit of normality
- Serum creatinine >2.5 mg/dl
- Serum creatine kinase (CK) over the upper limit of normality or known myopathy
- Known gastrointestinal or blood disease
- Pregnant or lactating women or women not protected by a contraception method
- Known hypersensibility to colchicine
- Treatment with colchicine at enrolment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Ospedali Riuniti
Bergamo, Bergamo
Ospedale Regionale Bolzano
Bolzano, Bolzano
Ospedale Niguarda
Milan, Milano
Ospedale di Rivoli
Rivoli
Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
Torino, Torino, 10141
Cardiac Surgery- Ospedale Mauriziano
Torino, Torino
About this study
Official title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The COPPS Trial: COlchicine for the Prevention of Postpericardiotomy Syndrome
The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.
Read the detailed description
The postpericardiotomy syndrome is a frequent complication after cardiac surgery affecting from 20 to 40% of patients. The etiology of this complication is a subject of debate. It is commonly believed to be an autoimmune response to pericardial and/or pleural bleeding or surgical trauma. Colchicine is safe and effective in the treatment and prevention of pericarditis and preliminary data have shown that it may be effective also in the primary prevention of the postpericardiotomy syndrome.
Comparisons: The study will compare the safety and efficacy of colchicine in the primary prevention of the postpericardiotomy syndrome in addition to optimal standard care.
- Conditions
- Postpericardiotomy Syndrome
- Being tested
- Colchicine (for 1 month)
- Keywords
- Postpericardiotomy Syndrome, Pericarditis, Prevention, Colchicine, Recurrence
- Medical subject headings
- Postpericardiotomy Syndrome, Pericarditis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine (for 1 month)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpericardiotomy syndrome
Measured: 12 months
Secondary outcomes (1)
Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postpericardiotomy SyndromeStudies 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
- Azienda Sanitaria Locale 3, Torino
- Sponsor type
- University, hospital or other
- Investigators
- Rita TRINCHERO, MD, Study chair, Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.Massimo IMAZIO, MD, Study chair, Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.Massimo IMAZIO, MD, Principal investigator, Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128427
- Sponsor's protocol ID
- DCASL30501-3
- Other IDs
- EUDRACT number 2005-001570-28
- Status last verified
- Jun 2010
- First submitted
- 8 Aug 2005
- Last updated
- 15 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Imazio M, Brucato A, Ferrazzi P, Rovere ME, Gandino A, Cemin R, Ferrua S, Belli R, Maestroni S, Simon C, Zingarelli E, Barosi A, Sansone F, Patrini D, Vitali E, Trinchero R, Spodick DH, Adler Y; COPPS Investigators. Colchicine reduces postoperative atrial fibrillation: results of the Colchicine for the Prevention of the Postpericardiotomy Syndrome (COPPS) atrial fibrillation substudy. Circulation. 2011 Nov 22;124(21):2290-5. doi: 10.1161/CIRCULATIONAHA.111.026153. Epub 2011 Nov 16.
PubMed 22090167Imazio M, Brucato A, Rovere ME, Gandino A, Cemin R, Ferrua S, Maestroni S, Zingarelli E, Barosi A, Simon C, Sansone F, Patrini D, Vitali E, Belli R, Ferrazzi P, Trinchero R, Spodick DH, Adler Y. Colchicine prevents early postoperative pericardial and pleural effusions. Am Heart J. 2011 Sep;162(3):527-32.e1. doi: 10.1016/j.ahj.2011.05.017. Epub 2011 Jul 18.
PubMed 21884871Imazio M, Trinchero R, Brucato A, Rovere ME, Gandino A, Cemin R, Ferrua S, Maestroni S, Zingarelli E, Barosi A, Simon C, Sansone F, Patrini D, Vitali E, Ferrazzi P, Spodick DH, Adler Y; COPPS Investigators. COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS): a multicentre, randomized, double-blind, placebo-controlled trial. Eur Heart J. 2010 Nov;31(22):2749-54. doi: 10.1093/eurheartj/ehq319. Epub 2010 Aug 30.
PubMed 20805112
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The COPPS Trial: COlchicine for the Prevention of Postpericardiotomy Syndrome
- ClinicalTrials.gov ID
- NCT00128427
- Acronym / sponsor ID
- DCASL30501-3
- Conditions
- Postpericardiotomy Syndrome
- Keywords
- Postpericardiotomy Syndrome, Pericarditis, Prevention, Colchicine, Recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale 3, TorinoUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Aug 2005 (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.
The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.
Detailed description
The postpericardiotomy syndrome is a frequent complication after cardiac surgery affecting from 20 to 40% of patients. The etiology of this complication is a subject of debate. It is commonly believed to be an autoimmune response to pericardial and/or pleural bleeding or surgical trauma. Colchicine is safe and effective in the treatment and prevention of pericarditis and preliminary data have shown that it may be effective also in the primary prevention of the postpericardiotomy syndrome.
Comparisons: The study will compare the safety and efficacy of colchicine in the primary prevention of the postpericardiotomy syndrome in addition to optimal standard care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in the third day after a cardiac surgery operation
- Age≥ 18 years
- Informed consent
Key exclusion criteria (8 listed)
- Known severe liver disease and/or elevated transaminases >1.5 times the upper limit of normality
- Serum creatinine >2.5 mg/dl
- Serum creatine kinase (CK) over the upper limit of normality or known myopathy
- Known gastrointestinal or blood disease
- Pregnant or lactating women or women not protected by a contraception method
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 |
|---|---|---|
| Colchicine (for 1 month) | Drug | – |
Primary outcome
Postpericardiotomy syndrome
Time frame: 12 months
1 secondary outcome
Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2010.
- Derived from this study: PubMed 22090167Imazio M, Brucato A, Ferrazzi P, Rovere ME, Gandino A, Cemin R, Ferrua S, Belli R, Maestroni S, Simon C, Zingarelli E, Barosi A, Sansone F, Patrini D, Vitali E, Trinchero R, Spodick DH, Adler Y; COPPS Investigators. Colchicine reduces postoperative atrial fibrillation: results of the Colchicine for the Prevention of the Postpericardiotomy Syndrome (COPPS) atrial fibrillation substudy. Circulation. 2011 Nov 22;124(21):2290-5. doi: 10.1161/CIRCULATIONAHA.111.026153. Epub 2011 Nov 16.
- Derived from this study: PubMed 21884871Imazio M, Brucato A, Rovere ME, Gandino A, Cemin R, Ferrua S, Maestroni S, Zingarelli E, Barosi A, Simon C, Sansone F, Patrini D, Vitali E, Belli R, Ferrazzi P, Trinchero R, Spodick DH, Adler Y. Colchicine prevents early postoperative pericardial and pleural effusions. Am Heart J. 2011 Sep;162(3):527-32.e1. doi: 10.1016/j.ahj.2011.05.017. Epub 2011 Jul 18.
- Derived from this study: PubMed 20805112Imazio M, Trinchero R, Brucato A, Rovere ME, Gandino A, Cemin R, Ferrua S, Maestroni S, Zingarelli E, Barosi A, Simon C, Sansone F, Patrini D, Vitali E, Ferrazzi P, Spodick DH, Adler Y; COPPS Investigators. COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS): a multicentre, randomized, double-blind, placebo-controlled trial. Eur Heart J. 2010 Nov;31(22):2749-54. doi: 10.1093/eurheartj/ehq319. Epub 2010 Aug 30.
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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.
Rita TRINCHERO, MD study chair
Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
Massimo IMAZIO, MD study chair
Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
Massimo IMAZIO, MD principal investigator
Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
6 sites 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 (for 1 month) in people with Postpericardiotomy Syndrome, run by Azienda Sanitaria Locale 3, Torino at 6 sites 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 8 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: finished, as of the sponsor's last update on 15 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postpericardiotomy syndrome (time frame: 12 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 NCT00128427, which also lists 3 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 15 Jun 2010.