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| Name | Class |
|---|---|
| French Federation of Cardiology | OTHER |
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Background: The incidence of asymptomatic pericardial effusion is high after cardiac surgery.
Objective: To assess whether colchicine is effective in reducing post operative pericardial effusion volume.
Design: Multicenter, randomized, double-blind, placebo-controlled study. Intervention : colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by echocardiography) more than 7 days after cardiac surgery.
Measurements: The main end point will be change in effusion grade after 14 days of treatment. Secondary endpoints include frequency of late cardiac tamponade.
Clinically insignificant pericardial effusion is common after heart surgery with an incidence of 50 % to 85 % a few days after surgery Cardiac tamponade occurs in about 1-2 % of patients who undergo cardiac surgery and may develop slowly without clear-cut clinical signs. Most tamponade occurs more than 7 days after surgery which is a concern because, at that time, patients often have already been discharged from the hospital.
No study has ever shown the efficacy any drug for this condition.In particular, we published a study demonstrating the absence of efficacy of a non steroidal anti inflammatory drug (Meurin P, Tabet JY, Thabut G, et al.French Society of Cardiology. Nonsteroidal anti-inflammatory drug treatment for postoperative pericardial effusion: a multicenter randomized, double-blind trial. Ann Intern Med. 2010 Feb2;152(3):137-43) Cochicine is widely used to treat inflammatory pericarditis ; is it efficient to treat post operative pericardial effusions ? this is the question we want to answer to.
Design: Multicenter, randomized, double-blind, placebo-controlled study. Intervention : colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by echocardiography) more than 7 days after cardiac surgery.
Measurements: The main end point will be change in effusion grade after 14 days of treatment. Secondary endpoints include frequency of late cardiac tamponade.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochicine | Experimental | Colchicine arm: patient receiving 1 mg per day for 14 days |
|
| Placebo | Placebo Comparator | patients placebo controlled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicines | Drug | oral form, 1 mg, once a day during 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change in effusion grade | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of late cardiac tamponade | 14 days | |
| number of patients with at least a one-grade decrease in the effusion | 14 days | |
| mean change in the width of the effusion measured in millimeters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Meurin, MD | Clinique Les Grands Près - Villeneuve Saint Denis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bois Gibert | Ballan-Miré | 37510 | France | |||
| Centre Médical de Bligny |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26076938 | Derived | Meurin P, Lelay-Kubas S, Pierre B, Pereira H, Pavy B, Iliou MC, Bussiere JL, Weber H, Beugin JP, Farrokhi T, Bellemain-Appaix A, Briota L, Tabet JY; French Society of Cardiology. Colchicine for postoperative pericardial effusion: a multicentre, double-blind, randomised controlled trial. Heart. 2015 Nov;101(21):1711-6. doi: 10.1136/heartjnl-2015-307827. Epub 2015 Jun 15. |
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| ID | Term |
|---|---|
| D010490 | Pericardial Effusion |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
oral form, placebo |
|
| 14 days |
| evolution of prespecified subgroups |
| 14 days |
| Briis-sous-Forges |
| 91640 |
| France |
| Clinique de Châtillon | Châtillon | 92320 | France |
| Centre Dieulefit Santé | Dieulefit | 26220 | France |
| Hopital Corentin Celton | Issy-les-Moulineaux | 92133 | France |
| Clinique de la mitterie | Lomme | 59160 | France |
| Centre Hospitalier Loire Vendée Océan | Machecoul | 44270 | France |
| Clinique Iris | Marcy-l'Étoile | 69280 | France |
| Maison du mineur | Vence | 06140 | France |
| Clinique les Grands Près | Villeneuve-Saint-Denis | 77174 | France |