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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 of acute pericarditis and the prevention of subsequent recurrences.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Conventional therapy plus placebo |
|
| Colchicine | Active Comparator | Conventional therapy plus colchicine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine (for 3 months) | Drug | Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate at 18 months | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom persistence at 72 hours, remission rate at 1 week | 1 week | |
| Number of recurrences | 18 months | |
| Time to first 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. Italy. | Study Chair |
| Massimo IMAZIO, 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino | Torino | Torino | 10141 | Italy | ||
| Internal Medicine Division |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17667033 | Background | 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. | |
| 23992557 |
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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 |
placebo |
|
| 18 months |
| Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study | 18 months |
| Bergamo |
| Italy |
| Cardiology Department-Ospedale Regionale | Bolzano | Italy |
| Ospedale di Rivoli | Rivoli | Italy |
| Derived |
| Imazio 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. |
| 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 |