PericarditisPhase 3NCT00128453
Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
A Phase 3 study testing Colchicine (for 3 months) in people with Pericarditis, run by Azienda Sanitaria Locale 3, Torino at 4 sites in Italy.
Trial summary
The purpose of the study is to determine whether colchicine is safe and effective in the treatment of acute pericarditis and the prevention of subsequent recurrences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pericarditis
- What is being tested?
- Colchicine (for 3 months)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 4 sitesItaly
- Study dates
- Aug 2005to Jun 2012
- 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 acute pericarditis (index attack)
- 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
4 sites in 1 country.
Italy4 sites
Internal Medicine Division
Bergamo
Cardiology Department-Ospedale Regionale
Bolzano
Ospedale di Rivoli
Rivoli
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino
Torino, Torino, 10141
About this study
Official title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The ICAP Trial: Investigation on Colchicine for Acute Pericarditis
The purpose of the study is to determine whether colchicine is safe and effective in the treatment of acute pericarditis and the prevention of subsequent recurrences.
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 index attack of pericarditis and the prevention of further recurrences.
Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of acute pericarditis and the primary prevention of recurrences. Colchicine will be used in addition to conventional treatment.
- Conditions
- Pericarditis
- Being tested
- Colchicine (for 3 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 3 months)Drug
Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Conventional therapy plus placebo Receives: Drug: Placebo |
| Colchicine | Active comparator | Conventional therapy plus colchicine Receives: Drug: Colchicine (for 3 months) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate at 18 months
Measured: 18 months
Secondary outcomes (4)
Symptom persistence at 72 hours, remission rate at 1 week
Measured: 1 week
Number of recurrences
Measured: 18 months
Time to first recurrence
Measured: 18 months
Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
Measured: 18 months
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 completionJun 2012
- Study completionJun 2012
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale 3, Torino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita TRINCHERO, MD, Study chair, Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.Massimo IMAZIO, MD, Study chair, Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.Massimo IMAZIO, MD, Principal investigator, Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128453
- Sponsor's protocol ID
- DCASL30501-1
- Other IDs
- EUDRACT number 2005-001570-28
- Status last verified
- Jun 2012
- First submitted
- 8 Aug 2005
- Last updated
- 7 Jun 2012
- Results posted
- No
Publications
Imazio M, Cecchi E, Ierna S, Trinchero R; ICAP Investigators. Investigation on Colchicine for Acute Pericarditis: a multicenter randomized placebo-controlled trial evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of pericarditis; study design amd rationale. J Cardiovasc Med (Hagerstown). 2007 Aug;8(8):613-7. doi: 10.2459/01.JCM.0000281702.46359.07.
PubMed 17667033Imazio M, Brucato A, Cemin R, Ferrua S, Maggiolini S, Beqaraj F, Demarie D, Forno D, Ferro S, Maestroni S, Belli R, Trinchero R, Spodick DH, Adler Y; ICAP Investigators. A randomized trial of colchicine for acute pericarditis. N Engl J Med. 2013 Oct 17;369(16):1522-8. doi: 10.1056/NEJMoa1208536. Epub 2013 Aug 31.
PubMed 23992557
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. 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 ICAP Trial: Investigation on Colchicine for Acute Pericarditis
- ClinicalTrials.gov ID
- NCT00128453
- Acronym / sponsor ID
- DCASL30501-1
- Conditions
- Pericarditis
- Keywords
- Pericarditis, Recurrence, Therapeutics, Prevention, Colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale 3, TorinoUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (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 of acute pericarditis and the prevention of subsequent recurrences.
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 index attack of pericarditis and the prevention of further recurrences.
Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of acute pericarditis and the primary prevention of recurrences. Colchicine will be used in addition to conventional treatment.
Study design
- Primary purpose
- Treatment
- 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: PlaceboConventional therapy plus placebo |
| Colchicine | Active comparator | Drug: Colchicine (for 3 months)Conventional therapy plus colchicine |
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 acute pericarditis (index attack)
- 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 3 months)Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily | Drug | Colchicine |
| Placeboplacebo | Drug | Placebo |
Primary outcome
Recurrence rate at 18 months
Time frame: 18 months
4 secondary outcomes
Symptom persistence at 72 hours, remission rate at 1 week
Time frame: 1 week
Number of recurrences
Time frame: 18 months
Time to first recurrence
Time frame: 18 months
Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
Time frame: 18 months
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 7 Jun 2012.
- Background: PubMed 17667033Imazio M, Cecchi E, Ierna S, Trinchero R; ICAP Investigators. Investigation on Colchicine for Acute Pericarditis: a multicenter randomized placebo-controlled trial evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of pericarditis; study design amd rationale. J Cardiovasc Med (Hagerstown). 2007 Aug;8(8):613-7. doi: 10.2459/01.JCM.0000281702.46359.07.
- Derived from this study: PubMed 23992557Imazio M, Brucato A, Cemin R, Ferrua S, Maggiolini S, Beqaraj F, Demarie D, Forno D, Ferro S, Maestroni S, Belli R, Trinchero R, Spodick DH, Adler Y; ICAP Investigators. A randomized trial of colchicine for acute pericarditis. N Engl J Med. 2013 Oct 17;369(16):1522-8. doi: 10.1056/NEJMoa1208536. Epub 2013 Aug 31.
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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. Italy.
Massimo IMAZIO, MD study chair
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
Massimo IMAZIO, MD principal investigator
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
4 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 3 months) in people with Pericarditis, run by Azienda Sanitaria Locale 3, Torino at 4 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 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 (time frame: 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 NCT00128453, 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 7 Jun 2012.