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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT number 2005-001570-28 |
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The purpose of the study is to determine whether colchicine is safe and effective in treatment and prevention of recurrent pericarditis after failure of conventional treatment.
Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data (observational, non-randomized studies without a control group) have shown that the drug may be effective in treatment of the second and subsequent recurrence and the prevention of further recurrences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental | Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months |
|
| Placebo | Placebo Comparator | Placebo 0.5mg BID (>70Kg) or 0.5 once daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate at 18 months | 18 m onths |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom persistence at 72 hours, remission rate at 1 week. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Imazio, MD | Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center) | Study Chair |
| Rita Trinchero, MD | Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center). | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center) | Torino | Torino | 10141 | Italy | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17885522 | Background | 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. | |
| 24694983 |
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| ID | Term |
|---|---|
| D010493 | Pericarditis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
Placebo comparator |
|
| Azienda Ospedaliera Papa Giovanni XXIII |
| Bergamo |
| Italy |
| Ospedale Regionale | Bolzano | Italy |
| Ospedale di Rivoli | Rivoli | Italy |
| Derived |
| Imazio M, Belli R, Brucato A, Cemin R, Ferrua S, Beqaraj F, Demarie D, Ferro S, Forno D, Maestroni S, Cumetti D, Varbella F, Trinchero R, Spodick DH, Adler Y. Efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis (CORP-2): a multicentre, double-blind, placebo-controlled, randomised trial. Lancet. 2014 Jun 28;383(9936):2232-7. doi: 10.1016/S0140-6736(13)62709-9. Epub 2014 Mar 30. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |