NCT01266694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2011

Typical duration for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

1.9 years

First QC Date

December 23, 2010

Last Update Submit

January 13, 2014

Conditions

Pericardial Effusion

Keywords

Pericardial effusionCardiac surgeryTamponadecolchicine

Outcome Measures

Primary Outcomes (1)

  • change in effusion grade

    14 days

Secondary Outcomes (4)

  • frequency of late cardiac tamponade

    14 days

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

    14 days

  • mean change in the width of the effusion measured in millimeters

    14 days

  • evolution of prespecified subgroups

    14 days

Study Arms (2)

Cochicine

EXPERIMENTAL

Colchicine arm: patient receiving 1 mg per day for 14 days

Drug: Colchicines

Placebo

PLACEBO COMPARATOR

patients placebo controlled

Drug: Placebo

Interventions

ColchicinesDRUG

oral form, 1 mg, once a day during 14 days

Cochicine
PlaceboDRUG

oral form, placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Bois Gibert

Ballan-Miré, 37510, France

Location

Centre Médical de Bligny

Briis-sous-Forges, 91640, France

Location

Clinique de Châtillon

Châtillon, 92320, France

Location

Centre Dieulefit Santé

Dieulefit, 26220, France

Location

Hopital Corentin Celton

Issy-les-Moulineaux, 92133, France

Location

Clinique de la mitterie

Lomme, 59160, France

Location

Centre Hospitalier Loire Vendée Océan

Machecoul, 44270, France

Location

Clinique Iris

Marcy-l'Étoile, 69280, France

Location

Maison du mineur

Vence, 06140, France

Location

Clinique les Grands Près

Villeneuve-Saint-Denis, 77174, France

Location

Related Publications (1)

  • 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.

    PMID: 26076938DERIVED

MeSH Terms

Conditions

Pericardial Effusion

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Philippe Meurin, MD

    Clinique Les Grands Près - Villeneuve Saint Denis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2010

First Posted

December 24, 2010

Study Start

April 1, 2011

Primary Completion

March 1, 2013

Study Completion

January 1, 2014

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

FR(10)