Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
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ClinicalTrials.gov Identifier: NCT00128453 |
Recruitment Status :
Completed
First Posted : August 10, 2005
Last Update Posted : June 7, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pericarditis | Drug: Colchicine (for 3 months) Drug: Placebo | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The ICAP Trial: Investigation on Colchicine for Acute Pericarditis |
Study Start Date : | August 2005 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Conventional therapy plus placebo
|
Drug: Placebo
placebo |
Active Comparator: Colchicine
Conventional therapy plus colchicine
|
Drug: Colchicine (for 3 months)
Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily |
- Recurrence rate at 18 months [ Time Frame: 18 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with acute pericarditis (index attack)
- Age≥ 18 years
- Informed consent
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128453
Italy | |
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino | |
Torino., Torino, Italy, 10141 | |
Internal Medicine Division | |
Bergamo, Italy | |
Cardiology Department-Ospedale Regionale | |
Bolzano, Italy | |
Ospedale di Rivoli | |
Rivoli, Italy |
Study Chair: | Rita TRINCHERO, MD | Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy. | |
Study Chair: | Massimo IMAZIO, MD | Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy. | |
Principal Investigator: | Massimo IMAZIO, MD | Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy. |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Azienda Sanitaria Locale 3, Torino |
ClinicalTrials.gov Identifier: | NCT00128453 History of Changes |
Other Study ID Numbers: |
DCASL30501-1 EUDRACT number 2005-001570-28 |
First Posted: | August 10, 2005 Key Record Dates |
Last Update Posted: | June 7, 2012 |
Last Verified: | June 2012 |
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