PericarditisPhase 3CORPNCT00128414
Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)
A Phase 3 study testing Colchicine (for 6 months) in people with Pericarditis and Recurrence, run by Azienda Sanitaria Locale 3, Torino at 5 sites in Italy.
Trial summary
The purpose of the study is to determine whether colchicine is safe and effective in the treatment and prevention of recurrent pericarditis (first episode). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pericarditis, Recurrence
- What is being tested?
- Colchicine (for 6 months)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 5 sitesItaly
- Study dates
- Aug 2005to Oct 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 with the first attack of recurrent pericarditis
- Age≥ 18 years
- Informed consent
Who cannot join
- Suspected neoplastic, tuberculous, or purulent etiology
- 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
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Internal Medicine Dpt. Ospedali Riuniti
Bergamo, Bergamo
Department of Cardiology, San Maurizio Regional Hospital
Bolzano, Bolzano
Ospedale di Rivoli
Rivoli
Cardiology Dpt. Ospedale SS Annunziata
Savigliano, CN
Cardiology Department. Maria Vittoria Hospital. ASL3 Torino
Torino, Torino, 10141
About this study
Official title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP Trial: COlchicine for Recurrent Pericarditis
The purpose of the study is to determine whether colchicine is safe and effective in the treatment and prevention of recurrent pericarditis (first episode).
Read the detailed description
Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data have shown that it may be effective also in treatment of the first attack of recurrent pericarditis and the prevention of further recurrences.
Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of the first attack of recurrent pericarditis and the secondary prevention of recurrences. Colchicine will be used in addition to conventional treatment.
- Conditions
- Pericarditis, Recurrence
- Being tested
- Colchicine (for 6 months), Placebo
- Keywords
- Pericarditis, Recurrence, Therapeutics, Prevention, Colchicine
- Medical subject headings
- Pericarditis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine (for 6 months)Drug
colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose.
PlaceboDrug
Tablets identical in colour, shape, and taste were provided in blister packs.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Comparator Receives: Drug: Placebo |
| Colchicine | Experimental | Colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 6 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose. Receives: Drug: Colchicine (for 6 months) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate at 18 months
Secondary outcomes (4)
Symptom persistence at 72 hours, remission rate at 1 week
Number of recurrences
Time to recurrence
Disease-related hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
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 startAug 2005
- Primary completionApr 2009
- Study completionOct 2010
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 PericarditisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 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 TorinoMassimo Imazio, MD, Study chair, Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.Massimo Imazio, MD, Principal investigator, Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128414
- Sponsor's protocol ID
- DCASL30501-2
- Other IDs
- EUDRACT number 2005-001570-28
- Acronym
- CORP
- Status last verified
- Feb 2011
- First submitted
- 8 Aug 2005
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Imazio M, Cecchi E, Ierna S, Trinchero R; CORP Investigators. CORP (COlchicine for Recurrent Pericarditis) and CORP-2 trials--two randomized placebo-controlled trials evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of recurrent pericarditis: study design and rationale. J Cardiovasc Med (Hagerstown). 2007 Oct;8(10):830-4. doi: 10.2459/JCM.0b013e3280110616.
PubMed 17885522Imazio M, Brucato A, Cemin R, Ferrua S, Belli R, Maestroni S, Trinchero R, Spodick DH, Adler Y; CORP (COlchicine for Recurrent Pericarditis) Investigators. Colchicine for recurrent pericarditis (CORP): a randomized trial. Ann Intern Med. 2011 Oct 4;155(7):409-14. doi: 10.7326/0003-4819-155-7-201110040-00359. Epub 2011 Aug 28.
PubMed 21873705
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. 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 CORP Trial: COlchicine for Recurrent Pericarditis
- ClinicalTrials.gov ID
- NCT00128414
- Acronym / sponsor ID
- CORP / DCASL30501-2
- Conditions
- Pericarditis, Recurrence
- Keywords
- Pericarditis, Recurrence, Therapeutics, Prevention, Colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale 3, TorinoUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 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 treatment and prevention of recurrent pericarditis (first episode).
Detailed description
Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data have shown that it may be effective also in treatment of the first attack of recurrent pericarditis and the prevention of further recurrences.
Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of the first attack of recurrent pericarditis and the secondary prevention of recurrences. Colchicine will be used in addition to conventional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator |
| Colchicine | Experimental | Drug: Colchicine (for 6 months)Colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 6 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose. |
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 with the first attack of recurrent pericarditis
- Age≥ 18 years
- Informed consent
Key exclusion criteria (8 listed)
- Suspected neoplastic, tuberculous, or purulent etiology
- 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
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 6 months)colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose. | Drug | Colchicine |
| PlaceboTablets identical in colour, shape, and taste were provided in blister packs. | Drug | Placebo |
Primary outcome
Recurrence rate at 18 months
4 secondary outcomes
Symptom persistence at 72 hours, remission rate at 1 week
Number of recurrences
Time to recurrence
Disease-related hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
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 16 Feb 2011.
- Background: PubMed 17885522Imazio M, Cecchi E, Ierna S, Trinchero R; CORP Investigators. CORP (COlchicine for Recurrent Pericarditis) and CORP-2 trials--two randomized placebo-controlled trials evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of recurrent pericarditis: study design and rationale. J Cardiovasc Med (Hagerstown). 2007 Oct;8(10):830-4. doi: 10.2459/JCM.0b013e3280110616.
- Derived from this study: PubMed 21873705Imazio M, Brucato A, Cemin R, Ferrua S, Belli R, Maestroni S, Trinchero R, Spodick DH, Adler Y; CORP (COlchicine for Recurrent Pericarditis) Investigators. Colchicine for recurrent pericarditis (CORP): a randomized trial. Ann Intern Med. 2011 Oct 4;155(7):409-14. doi: 10.7326/0003-4819-155-7-201110040-00359. Epub 2011 Aug 28.
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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. ASL3 Torino.
Massimo Imazio, MD principal investigator
Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.
5 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 6 months) in people with Pericarditis and Recurrence, run by Azienda Sanitaria Locale 3, Torino at 5 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 16 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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?
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?
Recurrence rate at 18 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 NCT00128414, 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 16 Feb 2011.