Cochicine Treatment for Post- Operative Pericardial Effusion

Condition(s) targeted: Pericardial Effusion

Intervention: Colchicines (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: French Cardiology Society

Official(s) and/or principal investigator(s):
Philippe Meurin, MD, Principal Investigator, Affiliation: Clinique Les Grands Près - Villeneuve Saint Denis

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.

Official title: Cochicine Treatment for Post- Operative Pericardial Effusion: The POPE 2 Study A Multicenter, Double-blind, Randomized Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: change in effusion grade

Secondary outcome:

frequency of late cardiac tamponade

number of patients with at least a one-grade decrease in the effusion

mean change in the width of the effusion measured in millimeters

evolution of prespecified subgroups

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- patients with recent cardiac surgery

- admitted for cardiac rehabilitation

- pericardial effusion > grade 2 (corresponds to a loculated effusion > 10

millimeters or a circumferential effusion of any size)on the first trans thoracic echocardiography performed more than 7 days after surgery Exclusion Criteria:

- patients who do not give written consent to participate

- pregnancy

- colchicine allergy;

- renal failure, which we define as a serum creatinine level > 250micromol/l or

clairance < 30 ml/mn

- heart transplantation,or correction of congenital heart anomalies cardiac surgery

more than 30 days before their first trans thoracic echocardiography pericardial effusion that requires immediate drainage.

Bois Gibert, Ballan Miré 37510, France

Centre Médical de Bligny, 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

Starting date: April 2011
Last updated: January 13, 2014