Cochicine Treatment for Post- Operative Pericardial Effusion (POPE2)

This study has been completed.
Sponsor:
Collaborator:
French Federation of Cardiology
Information provided by (Responsible Party):
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01266694
First received: December 23, 2010
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Pericardial Effusion
Drug: Colchicines
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cochicine Treatment for Post- Operative Pericardial Effusion: The POPE 2 Study A Multicenter, Double-blind, Randomized Trial

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • change in effusion grade [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • frequency of late cardiac tamponade [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • number of patients with at least a one-grade decrease in the effusion [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • mean change in the width of the effusion measured in millimeters [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • evolution of prespecified subgroups [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    • patients with inflammatory syndrom : crp > 30 mg/l
    • patients receiving an anticoagulant
    • patients with a post pericardiotomy syndrom


Enrollment: 199
Study Start Date: April 2011
Study Completion Date: January 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266694

Locations
France
Bois Gibert
Ballan Miré, France, 37510
Centre Médical de Bligny
Briis sous Forges, France, 91640
Clinique de Châtillon
Châtillon, France, 92320
Centre Dieulefit Santé
Dieulefit, France, 26220
Hopital Corentin Celton
Issy les moulineaux, France, 92133
Clinique de la mitterie
Lomme, France, 59160
Centre Hospitalier Loire Vendée Océan
Machecoul, France, 44270
Clinique Iris
Marcy l'étoile, France, 69280
Maison du mineur
Vence, France, 06140
Clinique les Grands Près
Villeneuve Saint Denis, France, 77174
Sponsors and Collaborators
French Cardiology Society
French Federation of Cardiology
Investigators
Principal Investigator: Philippe Meurin, MD Clinique Les Grands Près - Villeneuve Saint Denis
  More Information

No publications provided

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT01266694     History of Changes
Other Study ID Numbers: 2010-02
Study First Received: December 23, 2010
Last Updated: January 13, 2014
Health Authority: France: Ministry of Health

Keywords provided by French Cardiology Society:
Pericardial effusion
Cardiac surgery
Tamponade
colchicine

Additional relevant MeSH terms:
Pericardial Effusion
Heart Diseases
Cardiovascular Diseases
Colchicine
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 22, 2014