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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 the treatment and prevention of recurrent pericarditis (first episode).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo Comparator |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate at 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom persistence at 72 hours, remission rate at 1 week | ||
| Number of recurrences | ||
| Time to recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita TRINCHERO, MD | Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino | Study Chair |
| Massimo Imazio, MD | Cardiology Department. Maria Vittoria Hospital. ASL3 Torino. | Study Chair |
| Massimo Imazio, MD | Cardiology Department. Maria Vittoria Hospital. ASL3 Torino. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internal Medicine Dpt. Ospedali Riuniti | Bergamo | Bergamo | Italy | |||
| Department of Cardiology, San Maurizio Regional Hospital |
| 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. | |
| 21873705 |
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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 |
| D000074584 | WW Domain-Containing Oxidoreductase |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
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| Placebo | Drug | Tablets identical in colour, shape, and taste were provided in blister packs. |
|
| Disease-related hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study |
| Bolzano |
| Bolzano |
| Italy |
| Cardiology Dpt. Ospedale SS Annunziata | Savigliano | CN | Italy |
| Cardiology Department. Maria Vittoria Hospital. ASL3 Torino | Torino | Torino | 10141 | Italy |
| Ospedale di Rivoli | Rivoli | Italy |
| Derived |
| Imazio 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |