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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 prevention of the postpericardiotomy syndrome.
The postpericardiotomy syndrome is a frequent complication after cardiac surgery affecting from 20 to 40% of patients. The etiology of this complication is a subject of debate. It is commonly believed to be an autoimmune response to pericardial and/or pleural bleeding or surgical trauma. Colchicine is safe and effective in the treatment and prevention of pericarditis and preliminary data have shown that it may be effective also in the primary prevention of the postpericardiotomy syndrome.
Comparisons: The study will compare the safety and efficacy of colchicine in the primary prevention of the postpericardiotomy syndrome in addition to optimal standard care.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine (for 1 month) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Postpericardiotomy syndrome | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses |
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Inclusion Criteria:
Exclusion Criteria:
All evaluated before the surgical operation:
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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. ASL 3. Torino. | Study Chair |
| Massimo IMAZIO, MD | Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali Riuniti | Bergamo | Bergamo | Italy | |||
| Ospedale Regionale Bolzano |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22090167 | Derived | Imazio M, Brucato A, Ferrazzi P, Rovere ME, Gandino A, Cemin R, Ferrua S, Belli R, Maestroni S, Simon C, Zingarelli E, Barosi A, Sansone F, Patrini D, Vitali E, Trinchero R, Spodick DH, Adler Y; COPPS Investigators. Colchicine reduces postoperative atrial fibrillation: results of the Colchicine for the Prevention of the Postpericardiotomy Syndrome (COPPS) atrial fibrillation substudy. Circulation. 2011 Nov 22;124(21):2290-5. doi: 10.1161/CIRCULATIONAHA.111.026153. Epub 2011 Nov 16. | |
| 21884871 |
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| ID | Term |
|---|---|
| D011185 | Postpericardiotomy Syndrome |
| D010493 | Pericarditis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| 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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| Bolzano |
| Bolzano |
| Italy |
| Ospedale Niguarda | Milan | Milano | Italy |
| Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino. | Torino | Torino | 10141 | Italy |
| Cardiac Surgery- Ospedale Mauriziano | Torino | Torino | Italy |
| Ospedale di Rivoli | Rivoli | Italy |
| Derived |
| Imazio M, Brucato A, Rovere ME, Gandino A, Cemin R, Ferrua S, Maestroni S, Zingarelli E, Barosi A, Simon C, Sansone F, Patrini D, Vitali E, Belli R, Ferrazzi P, Trinchero R, Spodick DH, Adler Y. Colchicine prevents early postoperative pericardial and pleural effusions. Am Heart J. 2011 Sep;162(3):527-32.e1. doi: 10.1016/j.ahj.2011.05.017. Epub 2011 Jul 18. |
| 20805112 | Derived | Imazio M, Trinchero R, Brucato A, Rovere ME, Gandino A, Cemin R, Ferrua S, Maestroni S, Zingarelli E, Barosi A, Simon C, Sansone F, Patrini D, Vitali E, Ferrazzi P, Spodick DH, Adler Y; COPPS Investigators. COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS): a multicentre, randomized, double-blind, placebo-controlled trial. Eur Heart J. 2010 Nov;31(22):2749-54. doi: 10.1093/eurheartj/ehq319. Epub 2010 Aug 30. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| 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 |