Cochicine Treatment for Post- Operative Pericardial Effusion (POPE2)

January 13, 2014 updated by: French Cardiology Society

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Ballan Miré, France, 37510
        • Bois Gibert
      • Briis sous Forges, France, 91640
        • Centre Medical de Bligny
      • Châtillon, France, 92320
        • Clinique de Châtillon
      • Dieulefit, France, 26220
        • Centre Dieulefit Santé
      • Issy les moulineaux, France, 92133
        • Hôpital Corentin Celton
      • Lomme, France, 59160
        • Clinique de la Mitterie
      • Machecoul, France, 44270
        • Centre Hospitalier Loire Vendée Océan
      • Marcy l'étoile, France, 69280
        • Clinique Iris
      • Vence, France, 06140
        • Maison du mineur
      • Villeneuve Saint Denis, France, 77174
        • Clinique les Grands Près

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cochicine
Colchicine arm: patient receiving 1 mg per day for 14 days
Drug: Colchicines
oral form, 1 mg, once a day during 14 days
Placebo Comparator: Placebo
patients placebo controlled
Drug: Placebo
oral form, placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in effusion grade
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of late cardiac tamponade
Time Frame: 14 days
14 days
number of patients with at least a one-grade decrease in the effusion
Time Frame: 14 days
14 days
mean change in the width of the effusion measured in millimeters
Time Frame: 14 days
14 days
evolution of prespecified subgroups
Time Frame: 14 days
  • patients with inflammatory syndrom : crp > 30 mg/l
  • patients receiving an anticoagulant
  • patients with a post pericardiotomy syndrom
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Collaborators

French Federation of Cardiology

Investigators

  • Principal Investigator: Philippe Meurin, MD, Clinique Les Grands Près - Villeneuve Saint Denis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

December 23, 2010

First Submitted That Met QC Criteria

December 23, 2010

First Posted (Estimate)

December 24, 2010

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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