Clinical trial NCT01266694: Cochicine Treatment for Post- Operative Pericardial Effusion
Official title: Cochicine Treatment for Post- Operative Pericardial Effusion: The POPE 2 Study A Multicenter, Double-blind, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pericardial Effusion
Keywords: Pericardial effusion
Cardiac surgery
Tamponade
colchicine
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: French Federation of Cardiology
First posted: 2010-12-24
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: change in effusion grade
timeFrame: 14 days
Secondary outcomes:
measure: frequency of late cardiac tamponade
timeFrame: 14 days
measure: number of patients with at least a one-grade decrease in the effusion
timeFrame: 14 days
measure: mean change in the width of the effusion measured in millimeters
timeFrame: 14 days
measure: evolution of prespecified subgroups
timeFrame: 14 days
Other outcomes:
Locations:
city: Ballan Miré
country: France
facility: Bois Gibert
city: Briis sous Forges
country: France
facility: Centre Médical de Bligny
city: Châtillon
country: France
facility: Clinique de Châtillon
city: Dieulefit
country: France
facility: Centre Dieulefit Santé
city: Issy les moulineaux
country: France
facility: Hopital Corentin Celton
city: Lomme
country: France
facility: Clinique de la mitterie
city: Machecoul
country: France
facility: Centre Hospitalier Loire Vendée Océan
city: Marcy l'étoile
country: France
facility: Clinique Iris
city: Vence
country: France
facility: Maison du mineur
city: Villeneuve Saint Denis
country: France
facility: Clinique les Grands Près
Study officials:
affiliation: Clinique Les Grands Près - Villeneuve Saint Denis
name: Philippe Meurin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.