Cochicine Treatment for Post- Operative Pericardial Effusion

Pericardial Effusion Clinical Trial

— POPE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266694
• Other study ID #: 2010-02
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2010
• Last updated: January 13, 2014
• Start date: April 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: January 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pericardial Effusion

Intervention

Drug:
• Colchicines
oral form, 1 mg, once a day during 14 days
• Placebo
oral form, placebo

Locations

Country	Name	City	State
France	Bois Gibert	Ballan Miré
France	Centre Médical de Bligny	Briis sous Forges
France	Clinique de Châtillon	Châtillon
France	Centre Dieulefit Santé	Dieulefit
France	Hopital Corentin Celton	Issy les moulineaux
France	Clinique de la mitterie	Lomme
France	Centre Hospitalier Loire Vendée Océan	Machecoul
France	Clinique Iris	Marcy l'étoile
France	Maison du mineur	Vence
France	Clinique les Grands Près	Villeneuve Saint Denis

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	French Federation of Cardiology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in effusion grade		14 days	No
Secondary	frequency of late cardiac tamponade		14 days	No
Secondary	number of patients with at least a one-grade decrease in the effusion		14 days	No
Secondary	mean change in the width of the effusion measured in millimeters		14 days	No
Secondary	evolution of prespecified subgroups	patients with inflammatory syndrom : crp > 30 mg/l; patients receiving an anticoagulant; patients with a post pericardiotomy syndrom	14 days	No